Myocardial Ischemia and Transfusion (MINT)

Myocardial Ischemia and Transfusion: A Pilot, Multi-centre, Open-label Randomized Controlled Trial of Two Commonly Used Transfusion Strategies in Patients With Myocardial Infarction.

MINT: A pilot, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in patients with myocardial infarction.

Study Overview

• Status: Active, not recruiting
• Conditions: Myocardial Infarction
• Intervention / Treatment: Procedure: Transfusion

Detailed Description

Heart attacks are conditions where blood flow to the heart muscle is dangerously low - eventually causing heart muscle to die. Drugs improving the blood flow, and procedures such angioplasty, are the mainstay of therapies. They will only work if there is enough oxygen transported in blood. In fact, the heart may be deprived of oxygen not only because of the heart attack itself but also because of low blood counts (or anemia). Anemia, or low blood counts, may be caused by bleeding or by conditions such as cancer, kidney failure, chronic infections or conditions such as severe arthritis. A transfusion increases the delivery of oxygen to the heart muscle. However, we do not know at what level of anemia to initiate blood transfusion to prevent permanent heart damage. Indeed, having low blood counts may be harmful but blood transfusions also carries important risks including extra fluid in the lungs and heart inability to pump effectively.

In previous studies, investigators demonstrated that giving less blood is safer in most patients. But, there is little evidence in patients with heart attack. This first pilot trial aims to make sure that a large study that will answer the question is doable. The large trial aims to determine when and how much blood to give to minimize damage. In both studies, patients who have a heart attack will be divided into two groups in the hopes of preventing patients from dying. One group will receive more blood and the other group less blood. In the pilot trial, it will be evaluated if we can recruit patients with heart attack in a timely fashion. This trial will span over 12 months. If patient recruitment goes well, investigators will move ahead with the second phase of the project involving over 3500 patients. The numbers of patients who die or have another heart attack as well as if doctors follow treatment plans will be recorded. The 5-year large scale project will provide a definitive answer to the amount and optimal timing of blood transfusion.

• Study Type: Interventional
• Enrollment (Actual): 3501
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • Alberta Heart Institute
  • British Columbia
    • Victoria, British Columbia, Canada
      • Victoria Heart Institute
  • Quebec
    • Montreal, Quebec, Canada, H2X 0A9
      • Centre Hospitalier de l'Universite de Montreal-Hotel Dieu
    • Quebec City, Quebec, Canada
      • Institut Universitaire de Cardiologie et de Pneumologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Hospitalized patients with hemoglobin level less than 100 g/L who present with an ST-segment Elevation Myocardial Infarction (STEMI), or Non-ST-Elevation Myocardial Infarction (NSTEMI);
• Rise in cardiac biomarker values with at least one value above the 99th percentile (preferably cardiac troponin cTn )

• Presence of one of the following:

  • symptoms of ischemia;
  • new/presumed new ST segment-T wave (ST-T) changes or new left bundle branch (LBBB);
  • development of pathological Q waves;
  • imaging evidence of new loss of viable myocardium or new regional wall motion abnormality;
  • identification of an intracoronary thrombus by angiography

Exclusion Criteria:

• Patients with uncontrolled acute bleeding at the time of randomization defined as the need for uncrossed or non-type specific blood;
• Patients who decline blood transfusion;
• Patients who have a planned cardiac surgery or immediate post-cardiac surgery;Patients who have been deemed palliative by their treatment team (no commitment to aggressive on-going care);
• If known that follow-up will not be possible at 30 days;
• Previous participation in the MINT Trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Restrictive Transfusion Strategy; We will permit but not require red cell transfusions once a hemoglobin value falls below 80 g/L (required below 70 g/L) during the 30 days following randomization	Procedure: Transfusion; Red Blood Cell Transfusion
Active Comparator: Liberal Transfusion Strategy; We will transfuse at a transfusion threshold of 100 g/L for up to 30 days after randomization.	Procedure: Transfusion; Red Blood Cell Transfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment rate	Recruitment will be estimated over a 6 months period at each center	Time Frame: 6 months
Non-adherence	Non-adherence will be defined as transfusing a patient allocated to the restrictive group if the hemoglobin level is greater than 80 g/L; in the liberal group, not transfusing a patient who has a hemoglobin less than 100 g/L for at least 48 hours with at least 2 consecutive values.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrent non-fatal myocardial infarction	The 3rd Universal Definition of MI will be used. Recurrent MI within 30 days of the incident MI will require: a) an increase in troponin concentration of 20% or greater from the last measured value and b) clinical symptoms or signs including i) recurrence of ST elevation ≥0.1 mV, or new pathognomonic Q waves in at least two contiguous leads; or ii) ischemic symptoms for 20 minutes or longer. Acute myocardial infarction will be adjudicated by an independent blinded committee to minimize ascertainment bias.	30 days

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborators: Canadian Institutes of Health Research (CIHR); Canadian Blood Services
• Investigators: Principal Investigator: Paul Hébert, MD, Centre Hospitalier de l'Université de Montréal

Publications and helpful links

General Publications

• Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2016
• Primary Completion (Estimated): November 30, 2023
• Study Completion (Estimated): November 30, 2023

Study Registration Dates

• First Submitted: November 30, 2015
• First Submitted That Met QC Criteria: November 30, 2015
• First Posted (Estimated): December 2, 2015

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Blood Transfusion
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Infarction; Infarction; Coronary Artery Disease; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: MP-10-2016-2619

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No