Skip to main content
OpenTrials
Completed

NCT Number: NCT02981407

Myocardial Ischemia and Transfusion

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Flinders Medical Centre, Bedford Park, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

red blood cell transfusion

Biological

Transfusion of packed red blood cell units

Primary outcomes

  1. Number of Participants With All-cause Mortality or Nonfatal Myocardial Reinfarction

    Time frame: Within 30 days of randomization

Secondary outcomes

  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 outcomes

  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. 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

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Pittsburgh

Registry information

Acronym: MINT

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Dec 5, 2016
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.