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Myocardial Ischemia and Transfusion (MINT)

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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

Tracking Information
First Submitted Date  ICMJE December 1, 2016
First Posted Date  ICMJE December 5, 2016
Last Update Posted Date May 22, 2019
Actual Study Start Date  ICMJE April 25, 2017
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2016)
Composite outcome of all-cause mortality or nonfatal myocardial reinfarction [ Time Frame: Within 30 days of randomization ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02981407 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2016)
  • All-cause mortality [ Time Frame: Within 30 days of randomization ]
  • Myocardial reinfarction [ Time Frame: Within 30 days of randomization ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 1, 2016)
  • Composite of all-cause mortality,nonfatal myocardial reinfarction, or unstable angina [ Time Frame: Within 30 days of randomization ]
  • Ischemia driven unscheduled coronary revascularization [ Time Frame: Within 30 days of randomization ]
  • Unscheduled readmission to hospital for ischemic cardiac diagnosis [ Time Frame: Within 30 days of randomization ]
  • Congestive heart failure [ Time Frame: Within 30 days of randomization ]
  • Unscheduled readmission to hospital for any reason [ Time Frame: Within 30 days of randomization ]
  • Stroke [ Time Frame: Within 30 days of randomization ]
  • Pulmonary embolism or deep venous thrombosis [ Time Frame: Within 30 days of randomization ]
  • Bleed [ Time Frame: Within 30 days of randomization ]
  • Pneumonia [ Time Frame: Within 30 days of randomization ]
  • Blood stream infection [ Time Frame: Within 30 days of randomization ]
  • Urinary tract infection [ Time Frame: Within 30 days of randomization ]
  • Length of hospital stay post randomization [ Time Frame: Within 30 days of randomization ]
  • Number of days post randomization in intensive care unit [ Time Frame: Within 30 days of randomization ]
  • Patient reported quality of life [ Time Frame: Within 30 days of randomization ]
    EuroQol questionnaire
  • All-cause mortality [ Time Frame: Within 6 months of randomization ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Myocardial Ischemia and Transfusion
Official Title  ICMJE Myocardial Ischemia and Transfusion
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Myocardial Infarction
  • Anemia
Intervention  ICMJE Biological: Red Blood Cell Transfusion
Transfusion of packed red blood cell units
Study Arms  ICMJE
  • 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.
    Intervention: Biological: Red Blood Cell Transfusion
  • 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.
    Intervention: Biological: Red Blood Cell Transfusion
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 1, 2016)
3500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jeffrey L Carson, MD 732-235-7122 Jeffrey.Carson@Rutgers.edu
Contact: Helaine Noveck, MPH 732-235-6581 Helaine.Noveck@Rutgers.edu
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02981407
Other Study ID Numbers  ICMJE Pro20160000722
1U01HL133817-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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.
Responsible Party Jeffrey L Carson, MD, Rutgers, The State University of New Jersey
Study Sponsor  ICMJE Rutgers, The State University of New Jersey
Collaborators  ICMJE
  • University of Pittsburgh
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Jeffrey L Carson, MD Rutgers Robert Wood Johnson Medical School
Principal Investigator: Maria Mori Brooks, PhD University of Pittsburgh
PRS Account Rutgers, The State University of New Jersey
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP