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Trial record 1 of 1 for:    NCT02619136
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Myocardial Ischemia and Transfusion (MINT)

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ClinicalTrials.gov Identifier: NCT02619136
Recruitment Status : Unknown
Verified November 2015 by Centre hospitalier de l'Université de Montréal (CHUM).
Recruitment status was:  Not yet recruiting
First Posted : December 2, 2015
Last Update Posted : December 2, 2015
Sponsor:
Collaborators:
Canadian Blood Services
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

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

Condition or disease Intervention/treatment Phase
Myocardial Infarction Procedure: Transfusion Not Applicable

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, we 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, we will divide patients who have a heart attack 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, we will evaluate if we can recruit patients with heart attack in a timely fashion. This trial will span over 12 months. If patient recruitment goes well, we will move ahead with the second phase of the project involving over 3500 patients. We plan to record the numbers of patients who die or have another heart attack as well as if doctors follow treatment plans. The 5-year large scale project will provide a definitive answer to the amount and optimal timing of blood transfusion.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Enrollment rate [ Time Frame: Time Frame: 6 months ]

Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 30 days ]
  2. Recurrent non-fatal myocardial infarction [ Time Frame: 30 days ]
  3. Adherence rate [ Time Frame: 30 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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);

  • Definitive evidence of myocardial necrosis, and patients will have at least one of the following:

    1. symptoms of ischemia;
    2. new/presumed new ST segment-T wave (ST-T) changes or new left bundle branch block (LBBB);
    3. development of pathological Q waves;
    4. imaging evidence of new loss of viable myocardium or new regional wall motion abnormality; and/or
    5. identification of an intracoronary thrombus by angiography.
  • Type I and Type II myocardial infarction.

Exclusion Criteria:

  • Uncontrolled acute bleeding at the time of randomization defined as the need for uncrossed or non-type specific blood;
  • Decline blood transfusion;
  • Planned for cardiac surgery within 30 days;
  • Considered brain dead;
  • Have been deemed palliative by their treatment team (no commitment to aggressive on-going care);
  • With inability to cross match blood;
  • No contact information to assure post-discharge follow-up;
  • Cardiogenic shock.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02619136


Contacts
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Contact: Paul Hébert, MD 5148908000 paul.hebert.chum@ssss.gouv.qc.ca
Contact: Romain Rigal, PharmD, MSc 5142134692 romain.rigal.chum@ssss.gouv.qc.ca

Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Canadian Blood Services
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Paul Hébert, MD Centre hospitalier de l'Université de Montréal (CHUM)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT02619136    
Other Study ID Numbers: MP-10-2016-2619
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015
Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Blood Transfusion
Additional relevant MeSH terms:
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Myocardial Infarction
Myocardial Ischemia
Coronary Artery Disease
Infarction
Ischemia
Pathologic Processes
Necrosis
 Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases