Clinical trial NCT02619136: Myocardial Ischemia and Transfusion
Official title: Myocardial Ischemia and Transfusion: A Pilot, Multi-centre, Open-label Randomized Controlled Trial of Two Commonly Used Transfusion Strategies in Patients With Myocardial Infarction.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myocardial Infarction
Keywords: Blood Transfusion
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Canadian Blood Services
name: Canadian Institutes of Health Research (CIHR)
First posted: 2015-12-02
Enrollment: 3501
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Enrollment rate
timeFrame: Time Frame: 6 months
measure: Non-adherence
timeFrame: 30 days
Secondary outcomes:
measure: Recurrent non-fatal myocardial infarction
timeFrame: 30 days
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Alberta Heart Institute
state: Alberta
city: Victoria
country: Canada
facility: Victoria Heart Institute
state: British Columbia
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal-Hotel Dieu
state: Quebec
city: Quebec City
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie
state: Quebec
Study officials:
affiliation: Centre Hospitalier de l'Universite de Montreal
name: Paul Hébert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.