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Myocardial Ischemia and Transfusion (MINT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02981407
Recruitment Status : Recruiting
First Posted : December 5, 2016
Last Update Posted : May 22, 2019
Sponsor:
Collaborators:
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jeffrey L Carson, MD, Rutgers, The State University of New Jersey

Brief Summary:
The purpose of this study is to compare two red blood cell transfusion strategies (liberal and restrictive) for patients who have had an acute myocardial infarction and are anemic.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Anemia Biological: Red Blood Cell Transfusion Phase 3

Detailed Description:

In most clinical settings, evidence suggests it is safe to wait to give a blood transfusion. However, for those who have suffered a heart attack, there is a lack of high quality evidence to guide transfusions. This 3500 subject multi-center randomized trial will fill that void.

Hospital inpatients diagnosed with myocardial infarction who have blood counts less than 10 g/dL are randomized to receive either a liberal or a restrictive transfusion strategy.

Patients randomized to the liberal transfusion strategy will receive a red blood cell transfusion anytime there is a blood count of less than 10 g/dL.

Patients randomized to the restrictive transfusion strategy are permitted to receive a blood transfusion if the blood count is below 8 g/dL and the physician believes it is in the patient's best interest. A transfusion will be strongly recommended if the blood count drops to less than 7 g/dL. If the patient has symptoms of angina (e.g., chest discomfort described as pressure or heaviness) that do not go away with medication, a blood transfusion is ordered regardless of the blood count.

The transfusions strategies will be maintained until hospital discharge for a maximum of 30 days.

Patients will be followed for 30 days for clinically relevant outcomes. Vital status will be confirmed at 180 days.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Myocardial Ischemia and Transfusion
Actual Study Start Date : April 25, 2017
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Liberal Transfusion Strategy
Red blood cell transfusion - One unit of packed red cells is transfused following randomization followed by enough red blood cell units to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days.
Biological: Red Blood Cell Transfusion
Transfusion of packed red blood cell units

Active Comparator: Restrictive Transfusion Strategy
Permitted to receive a red blood cell transfusion if the blood count is below 8 g/dL and the physician believes it is in the patient's best interest. A transfusion will be strongly recommended if the blood count drops to less than 7 g/dL. If the patient has symptoms of angina (e.g., chest discomfort described as pressure or heaviness) that do not go away with medication, a blood transfusion will be ordered regardless of the blood count.
Biological: Red Blood Cell Transfusion
Transfusion of packed red blood cell units




Primary Outcome Measures :
  1. Composite outcome of all-cause mortality or nonfatal myocardial reinfarction [ Time Frame: Within 30 days of randomization ]

Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: Within 30 days of randomization ]
  2. Myocardial reinfarction [ Time Frame: Within 30 days of randomization ]
  3. Composite of all-cause mortality, nonfatal myocardial reinfarction, ischemia driven unscheduled coronary revascularization, or readmission to the hospital for ischemic cardiac diagnosis [ Time Frame: Within 30 days of randomization ]

Other Outcome Measures:
  1. Composite of all-cause mortality,nonfatal myocardial reinfarction, or unstable angina [ Time Frame: Within 30 days of randomization ]
  2. Ischemia driven unscheduled coronary revascularization [ Time Frame: Within 30 days of randomization ]
  3. Unscheduled readmission to hospital for ischemic cardiac diagnosis [ Time Frame: Within 30 days of randomization ]
  4. Congestive heart failure [ Time Frame: Within 30 days of randomization ]
  5. Unscheduled readmission to hospital for any reason [ Time Frame: Within 30 days of randomization ]
  6. Stroke [ Time Frame: Within 30 days of randomization ]
  7. Pulmonary embolism or deep venous thrombosis [ Time Frame: Within 30 days of randomization ]
  8. Bleed [ Time Frame: Within 30 days of randomization ]
  9. Pneumonia [ Time Frame: Within 30 days of randomization ]
  10. Blood stream infection [ Time Frame: Within 30 days of randomization ]
  11. Urinary tract infection [ Time Frame: Within 30 days of randomization ]
  12. Length of hospital stay post randomization [ Time Frame: Within 30 days of randomization ]
  13. Number of days post randomization in intensive care unit [ Time Frame: Within 30 days of randomization ]
  14. Patient reported quality of life [ Time Frame: Within 30 days of randomization ]
    EuroQol questionnaire

  15. All-cause mortality [ Time Frame: Within 6 months of randomization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Either ST segment elevation myocardial infarction or Non ST segment elevation myocardial infarction consistent with the 3rd Universal Definition of Myocardial Infarction criteria that occurs on admission or during the index hospitalization
  • Hemoglobin concentration less than 10 g/dL at the time of random allocation
  • Patient physician believes that both of the transfusion strategies are consistent with good medical care for the patient

Exclusion Criteria:

  • Uncontrolled acute bleeding at the time of randomization defined as the need for uncrossed or non-type specific blood
  • Decline blood transfusion
  • Scheduled for cardiac surgery during the current admission
  • Receiving only palliative treatment
  • Known that follow-up will not be possible at 30 days
  • Previously participated in MINT
  • Currently enrolled in a competing study that interferes with the intervention or follow-up of MINT or enrolled in a competing study that has not been approved by the local Institutional Review Board
  • Patient physician does not believe the patient is an appropriate candidate for the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981407


Contacts
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Contact: Jeffrey L Carson, MD 732-235-7122 Jeffrey.Carson@Rutgers.edu
Contact: Helaine Noveck, MPH 732-235-6581 Helaine.Noveck@Rutgers.edu

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Locations
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United States, Arkansas
Central Arkansas Veterans Healthcare System Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Kristin Miller, RN CCRC         
Principal Investigator: Barry Uretsky, MD         
University of Arkansas Medical Sciences (UAMS) Hospital Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Kristin Miller, RN CCRC         
Principal Investigator: Srikanth Vallurupalli, MD         
United States, California
VAGLAHS Recruiting
Los Angeles, California, United States, 90073
Contact: Michelle Treadwell         
Principal Investigator: Ramin Ebrahimi, MD         
United States, Connecticut
Danbury Hospital Recruiting
Danbury, Connecticut, United States, 06810
Contact: Kimberly Bowers         
Principal Investigator: Hal Wasserman, MD         
United States, Florida
Mount Sinai Medical Center Recruiting
Miami, Florida, United States, 33140
Contact: Juana Camus         
Principal Investigator: Lydia Howard, MD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Kirsten Hendrickson         
Principal Investigator: Raj C Shah, MD         
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Mary Harris-Moreno         
Principal Investigator: Tamar Tamar, MD         
Alexian Brothers Medical Center Recruiting
Elk Grove Village, Illinois, United States, 60007
Contact: Tina Warren         
Principal Investigator: Paul Greunwald, MD         
AMITA Health Recruiting
Hinsdale, Illinois, United States, 60521
Contact: Claudia Eaton, MS, RN         
Principal Investigator: Meechai Tessalee, MD         
United States, Kansas
Saint Luke's Mid America Heart Recruiting
Kansas City, Kansas, United States, 64111
Contact: Dana King, RCIS         
Principal Investigator: Adam C Salisbury, MD         
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Sharon Vincent, MSN, RN         
Principal Investigator: Andrew DeFilippis, MD         
United States, Louisiana
Tulane University School of Medicine Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Nana O Asafu-Adjaye         
Principal Investigator: Robert C Hendel, MD, FACC, FAHA, MASNC         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 01930
Contact: Cristina Brueggeman, RN         
Principal Investigator: Christopher Stowell, MD         
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Denise Fine         
Principal Investigator: Omar Siddiqi, MD         
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 15261
Contact: Betsy Malynn, RN         
Principal Investigator: Lynn Uhl, MD         
Lahey Hospital Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Judy Pendleton, BSN, RN         
Principal Investigator: Paolo Mascari, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Allison Schley         
Principal Investigator: Michael P Thomas, MD         
St. Joseph Mercy Health System Recruiting
Ypsilanti, Michigan, United States, 48197
Contact: Kristina Wippler, RN, MHA         
Principal Investigator: Mansoor Qureshi, MD         
United States, Minnesota
Essentia Health Recruiting
Duluth, Minnesota, United States, 55805
Contact: Jennifer Gunderson, RN, CCRC         
Principal Investigator: Wilson Ginete, MD         
University of Minnesota Medical Center Fairview Recruiting
Minneapolis, Minnesota, United States, 55105
Contact: Coley Landvik, RN         
Principal Investigator: Ganesh Raveendran, MD         
Minneapolis Heart Institute (Foundation) Recruiting
Minneapolis, Minnesota, United States, 55407-1130
Contact: Rose Peterson, RN BA CCRP         
Principal Investigator: Jay Traverse, MD         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Humaira Naseer, PhD         
Principal Investigator: Gregory W Barsness, MD         
United States, Mississippi
Memorial Hospital at Gulfport Recruiting
Gulfport, Mississippi, United States, 39502
Contact: Brandy Williams, MSN         
Principal Investigator: Paul Mullen, MD         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Margie Palazzolo, BSN         
Principal Investigator: Richard Bach, MD         
United States, New Jersey
Copper University Hospital Recruiting
Camden, New Jersey, United States, 08103
Contact: Leana Abreu, CCRC III         
Principal Investigator: Perry Weinstock, MD         
Hackensacjk University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: David Lai, RN, BSN         
Principal Investigator: David Landers, MD         
Jersey Shore University Medical Recruiting
Neptune, New Jersey, United States, 08759
Contact: Lynda Argenzio, RN         
Principal Investigator: Michael Carson, MD         
Robert Wood Johnson University Hospital Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Jeffrey L Carson, MD    732-235-7122    jeffrey.carson@rutgers.edu   
Principal Investigator: Jeffrey L Carson, MD         
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Judith Mondragon, RN, BSN         
Principal Investigator: Warren K Laskey, MD         
Sub-Investigator: Michael Gaglia         
United States, New York
Albany Medical College Recruiting
Albany, New York, United States, 12208
Contact: Wendy Stewart         
Principal Investigator: Joshua Schulman-Marcus, MD         
Southside Hospital Recruiting
Bay Shore, New York, United States, 11706
Contact: Barbara Shannon, RN CCRC         
Principal Investigator: Luis Gruberg, MD         
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Cristal Garcia         
Principal Investigator: Mark Menegus, MD         
NYP Brooklyn Methodist Recruiting
Brooklyn, New York, United States, 11215
Contact: Mahmoud Mohamed, MD         
Principal Investigator: Sorin Brener, MD         
New York Presbyterian/Queens Recruiting
Flushing, New York, United States, 11355
Contact: Asif Adam, CMA         
Principal Investigator: Xuming Dai, MD         
Westchester Medical Center Recruiting
Hawthorne, New York, United States, 10532
Contact: Anuritha Tirumani         
Principal Investigator: Howard Cooper, MD         
NYU Langone Medical Center, Bellevue Hospital Recruiting
New York, New York, United States, 10016
Contact: Karry Calderon         
Principal Investigator: Norma Keller, MD         
Lenox Hilll Hospital Recruiting
New York, New York, United States, 10075
Principal Investigator: Robert Roswell, MD         
Rochester General Hospital Recruiting
Rochester, New York, United States, 14450
Contact: Patricia Noll, RN         
Principal Investigator: Farhad Abtahian, MD         
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Carol Yeager, RN BS CCRC         
Principal Investigator: Joseph Delehanty, MD         
Northwell Staten Island Hopsital Recruiting
Staten Island, New York, United States, 10305
Contact: Maria Scibilia, RN, C-CRC         
Principal Investigator: Gregory Maniatis, MD         
Stony Brook Medicine Recruiting
Stony Brook, New York, United States, 11794-8167
Contact: Ruth Tenzler Stein, RN BSN         
Principal Investigator: William Lawson, MD         
United States, North Carolina
The University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7097
Contact: Janet Bogan, BS         
Principal Investigator: Josehph Rossi, MD         
Durham Va Recruiting
Durham, North Carolina, United States, 27705
Principal Investigator: Sunil Rao, MD         
WakeMed Health and Hospital Recruiting
Raleigh, North Carolina, United States, 27610
Contact: LaMonica Daniel         
Principal Investigator: Frances Wood, MD         
United States, Ohio
Aultman Hospital Recruiting
Canton, Ohio, United States, 44710
Contact: Jeannie Archinai         
Principal Investigator: Brendan Duffy, MD         
University of Toledo Medical Center Recruiting
Toledo, Ohio, United States, 43614
Contact: Stephanie Frank, BSN,RN,CCRC         
Principal Investigator: Ganesh Raveendran, MD         
United States, Pennsylvania
Lancaster General Hospital Recruiting
Lancaster, Pennsylvania, United States, 17602
Principal Investigator: Jason Scott, MD         
PENN Presbyterian Medical Cente Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Karen Maslowski, BSN, RN         
Principal Investigator: William H Matthai, MD         
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Barbara Gallagher, RN         
Principal Investigator: Gregary Marhefka, MD         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Megan Basch, RN         
Principal Investigator: Mark Schmidhofer, MD         
Lankenau Medical Center Recruiting
Wynnewood, Pennsylvania, United States, 19096
Principal Investigator: Jonathan Doroshow, MD         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Kelly Franchetti, RN         
Principal Investigator: J. Dawn Abbott, MD         
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Elizabeth Coccio, BSN         
Principal Investigator: Herbert Aronow, MD         
United States, South Carolina
Greenville Health System Recruiting
Greenville, South Carolina, United States, 29605
Contact: Grace Jones         
Principal Investigator: Craig M Hudak, MD         
United States, Tennessee
The Memphis VAMC Recruiting
Memphis, Tennessee, United States, 38104
Contact: Ashley Armstrong, RN         
Principal Investigator: Kodangudi Ramanthan, MD         
United States, Texas
Baylor St Luke's Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Gilberto De Freitas, RN CCRC         
Principal Investigator: Arthur Bracey, MD         
United States, Vermont
University of Vermont Medical Center Recruiting
Burlington, Vermont, United States, 05401
Contact: Molly Raftery, RN         
Principal Investigator: Friederike Keating, MD         
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Laura H Johnson, BSN         
Principal Investigator: Michael Kontos, MD         
United States, Wisconsin
Medical College of Wisconsin - Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Barbara Shimada-Krouwer, RN BSB         
Principal Investigator: Michael Gitter, MD         
Canada, Alberta
Foothills Medical Centre Recruiting
Calgary, Alberta, Canada
Principal Investigator: Gregory Schnell         
Grey Nuns Community Hospital Recruiting
Edmonton, Alberta, Canada
Principal Investigator: Manohara Senaratne         
Royal Alexandra Hospital Recruiting
Edmonton, Alberta, Canada
Principal Investigator: Neil Brass         
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada
Principal Investigator: Kevin R Bainey         
Canada, British Columbia
Royal Columbian Hospital Recruiting
New Westminster, British Columbia, Canada
Principal Investigator: Razi Khan         
Surrey Memorial Hospital Recruiting
Surrey, British Columbia, Canada
Principal Investigator: Rajesh Hiralal         
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada
Principal Investigator: Christopher Fordyce         
Canada, Manitoba
St. Boniface General Hospital Recruiting
Winnipeg, Manitoba, Canada
Principal Investigator: Kunal Minhas         
Principal Investigator: John Ducas         
Canada, Nova Scotia
QE II Health Sciences Center Recruiting
Halifax, Nova Scotia, Canada
Principal Investigator: Ata Ur Rehman Quraishi         
Canada, Ontario
Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada
Principal Investigator: Vikas Tandon         
Hamilton St. Joseph's Health Recruiting
Hamilton, Ontario, Canada
Principal Investigator: Tandon Vikas         
St. Joseph's Health Centre Recruiting
Hamilton, Ontario, Canada
Principal Investigator: John Neary         
University Hospital - LHSC Recruiting
London, Ontario, Canada
Principal Investigator: Terry McPherson         
Victoria Hospital - LHSC Recruiting
London, Ontario, Canada
Principal Investigator: Terry McPherson         
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada
Principal Investigator: Akshay Bagai         
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada
Principal Investigator: Minakshi Madan         
Victoria Heart Institute Recruiting
Victoria, Ontario, Canada
Principal Investigator: Simon Robinson         
Canada, Quebec
Hôpital Charles Lemoyne Recruiting
Greenfield Park, Quebec, Canada
Principal Investigator: David Laflamme         
Hotel-Dieu de Levis Recruiting
Levis, Quebec, Canada
Principal Investigator: Nicolas Michaud         
Jewish General Hospital Recruiting
Montreal, Quebec, Canada
Principal Investigator: Michael Goldfarb         
Centre Hosp. Universitaire de Montréal Recruiting
Montréal, Quebec, Canada
Principal Investigator: Brian Potter         
Principal Investigator: François-Martin Carrier         
Montreal General Hospital Recruiting
Montréal, Quebec, Canada
Principal Investigator: Thao Huynh         
Royal Victoria Hospital Recruiting
Montréal, Quebec, Canada
Principal Investigator: Richard Haichin         
Quebec Heart and Lung Institute Recruiting
Québec City, Quebec, Canada
Principal Investigator: Jean-Pierre Dery         
Centre Hospitalier Universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada
Principal Investigator: Benoît Daneault         
General Hospital Trois-Rivièrs Recruiting
Trois-Rivières, Quebec, Canada
Principal Investigator: Sia Ying Tung Sia         
Canada, Saskatchewan
Regina General Hospital Recruiting
Regina, Saskatchewan, Canada
Principal Investigator: Payam Dehghani         
Sponsors and Collaborators
Rutgers, The State University of New Jersey
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Jeffrey L Carson, MD Rutgers Robert Wood Johnson Medical School
Principal Investigator: Maria Mori Brooks, PhD University of Pittsburgh

Publications:
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Responsible Party: Jeffrey L Carson, MD, Principal Investigator, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT02981407     History of Changes
Other Study ID Numbers: Pro20160000722
1U01HL133817-01 ( U.S. NIH Grant/Contract )
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Limited access data (i.e., records without personal identifiers) will be prepared by the Data Coordinating Center (DCC) and sent to the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) within 3 years after the end of the final patient follow-up or 2 years after the main paper of the trial has been published, whichever comes first. The Trial data set will include baseline patient characteristics, follow-up status, and clinical outcome data. The data will be released to requesting institutions and investigators in accordance with BioLINCC policy.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jeffrey L Carson, MD, Rutgers, The State University of New Jersey:
Red Blood Cell Transfusion
Anemia
Heart Disease
Cardiovascular Disease
Additional relevant MeSH terms:
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Myocardial Infarction
Myocardial Ischemia
Coronary Artery Disease
Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases