Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : September 10, 2018
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.


Layout table for study information
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Layout table for location contacts
Contact: Jeffrey L Carson, MD 732-235-7122 Jeffrey.Carson@Rutgers.edu
Contact: Helaine Noveck, MPH 732-235-6581 Helaine.Noveck@Rutgers.edu

  Show 55 Study Locations
Sponsors and Collaborators
Rutgers, The State University of New Jersey
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Layout table for investigator information
Principal Investigator: Jeffrey L Carson, MD Rutgers Robert Wood Johnson Medical School
Principal Investigator: Maria Mori Brooks, PhD University of Pittsburgh

Publications:
Layout table for additonal information
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: September 10, 2018
Last Verified: September 2018
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.

Layout table for additional information
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:
Layout table for MeSH terms
Infarction
Myocardial Infarction
Ischemia
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases