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Completed

NCT Number: NCT01167582

Myocardial Ischemia and Transfusion Pilot

The purpose of this study is to evaluate two approaches to red blood cell transfusion in anemic patients with acute coronary syndrome.

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Key information

About this study

Red blood cell transfusions are extremely common medical interventions, yet, it remains unclear when patients should be transfused. This pilot study will evaluate the feasibility of conducting a research protocol that will lead to a large scale clinical trial designed to evaluate the treatment effectiveness of two transfusion threshold strategies in patients with coronary artery disease.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age 18 or older;
  • STEMI (ST segment elevated myocardial infarction)
  • NSTEMI (Non ST segment elevation myocardial infarction)
  • unstable angina
  • stable coronary artery disease (undergoing cardiac catheterization during the index hospitalization);
  • written informed consent has been obtained
  • hemoglobin concentration less than 10 g/dL at the time of random allocation.

Exclusion criteria

  • bleeding cannot be controlled at the cardiac catheterization puncture site and/or require surgery to repair vessel
  • retroperitoneal bleeding requiring surgery
  • clinically important hemodynamic instability based on the judgment of the treating physician
  • terminal malignancy or life expectancy less than 6 months
  • scheduled for cardiac surgery within the next 30 days
  • symptomatic at the time of randomization
  • declines blood transfusion
  • history of a clinically significant transfusion reaction
  • inability to provide informed consent;
  • enrolled in a competing study
  • previous participation in the MINT trial
  • any patient who in the judgment of the research team should not be enrolled in the trial. This would include, but not be limited to, factors such alcohol or drug dependence, or psychiatric illness.

Treatment and study plan

red blood cell transfusion

Biological

Liberal versus restrictive transfusion

Primary outcomes

  1. Hemoglobin Concentration

    Time frame: In-hospital up to 30 days post randomization

    Differences in the mean hemoglobin concentrations between the two study arms.

  2. Red Blood Cell Transfusion

    Time frame: In-hospital up to 30 days post randomization

    Differences in mean number of units of red blood cell transfusions between the two study arms.

Secondary outcomes

  1. Mortality or Myocardial Ischemia

    Time frame: 30 days

    Composite 30 day rates of all cause 30 day mortality, or myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction) up to 30 days after randomization, or unscheduled coronary revascularization within 30 days.

  2. Mortality or Myocardial Ischemia

    Time frame: 6 months

    Composite 6 month rates of all cause 6 month mortality, recurrent myocardial infarction up to 6 months after randomization, unscheduled coronary revascularization within 6 months.

  3. Individual Components of Composite Outcome

    Time frame: 30 days

    All cause mortality Myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction) Unscheduled coronary revascularization.

  4. Mortality From Cardiac Causes

    Time frame: 30 days

  5. Unscheduled Hospital Admission

    Time frame: 30 days

    Unscheduled hospital admission at 30 days for any reason, for cardiac reason (e.g., acute coronary syndrome, MI, congestive heart failure, or arrhythmia), or infection.

  6. Stroke

    Time frame: 30 days

  7. Congestive Heart Failure

    Time frame: 30 days

  8. Stent Thrombosis

    Time frame: 30 days

  9. Deep Vein Thrombosis or Pulmonary Embolism

    Time frame: 30 days

  10. Pneumonia or Blood Stream Infection and Each Separately

    Time frame: 30 days

  11. Composite Mortality and Morbidity

    Time frame: 30 days

    Composite rates of all cause mortality, or myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction), or unscheduled coronary revascularization or pneumonia.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • Albert Einstein College of Medicine
  • Brigham and Women's Hospital
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Rhode Island Hospital
  • University of Pittsburgh

Registry information

Acronym: MINT Pilot

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jul 22, 2010
Registry last updated
Mar 20, 2019

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.

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