Myocardial Ischemia and Transfusion Pilot (MINT Pilot)

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Myocardial Infarction; Unstable Angina; Coronary Artery Disease	Biological: Red blood cell transfusion	Phase 3

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	110 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Myocardial Ischemia and Transfusion Pilot
Study Start Date :	September 2009
Actual Primary Completion Date :	June 2012
Actual Study Completion Date :	June 2012

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Liberal Transfusion Strategy; Patients randomly allocated to the liberal transfusion strategy receive one unit of packed red cells following randomization and receive enough blood to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days. Any transfusion following the initial unit of packed red cells must be preceded by blood test documenting a hemoglobin concentration below 10 g/dL.	Biological: Red blood cell transfusion; Liberal versus restrictive transfusion
Experimental: Restrictive transfusion strategy; Receive a transfusion if they develop symptoms related to anemia. Transfusion is also permitted, but not required, in the absence of symptoms only if the hemoglobin concentration falls below 8 g/dL. Blood is administered one unit at a time and the presence of symptoms is reassessed. Only enough blood is given to relieve symptoms. If the transfusion is given because the hemoglobin concentration falls below 8 g/dL, then only enough blood is given to increase the hemoglobin concentration above 8 g/dL. Symptoms of anemia that will be indications for transfusion are: 1) Definite angina requiring treatment with sublingual nitroglycerin or equivalent therapy. 2) Unexplained tachycardia or hypotension.	Biological: Red blood cell transfusion; Liberal versus restrictive transfusion

Outcome Measures

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Primary Outcome Measures :

1. Trial Feasibility [ Time Frame: 6 months ]
   1. the number of eligible study subjects and enrollment rates, overall and by center;
   2. the adherence rates for the transfusion protocol, overall and by center;
   3. the frequencies of proposed outcomes
2. Hemoglobin Concentration [ Time Frame: In-hospital up to 30 days post randomization ]
   Differences in the mean hemoglobin concentrations between the two study arms.
3. 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 Outcome Measures :

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 and 6 months ]
   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 and 6 months ]
5. Unscheduled Hospital Admission [ Time Frame: 30 days and 6 months ]
   Unscheduled hospital admission at 30 days and 6 months 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 and 6 months ]
7. Congestive Heart Failure [ Time Frame: 30 days and 6 months ]
8. Stent Thrombosis [ Time Frame: 30 days and 6 months ]
9. Deep Vein Thrombosis and Pulmonary Embolism [ Time Frame: 30 days and 6 months ]
10. Pneumonia or Blood Stream Infection and Each Separately [ Time Frame: 30 days and 6 months ]
11. Composite Mortality and Morbidity [ Time Frame: 30 days and 6 months ]
    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 and pneumonia.

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:

• 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.

Contacts and Locations

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Locations

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120
United States, New Jersey
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461-2301
Jack D. Weiler Hospital of Montefiore Medical Center
New York, New York, United States, 10461
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
University of Pittsburgh Data Coordinating Center
Pittsburgh, Pennsylvania, United States, 15261
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903

Sponsors and Collaborators

Rutgers, The State University of New Jersey

National Heart, Lung, and Blood Institute (NHLBI)

University of Pittsburgh

Albert Einstein College of Medicine, Inc.

Brigham and Women's Hospital

Rhode Island Hospital

Investigators

Study Chair:	Jeffrey L Carson, MD	Rutgers, The State University of New Jersey
Principal Investigator:	Sheryl F Kelsey, PhD	University of Pittsburgh Data Coordinating Center

More Information

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Publications of Results:

Carson JL, Brooks MM, Abbott JD, Chaitman B, Kelsey SF, Triulzi DJ, Srinivas V, Menegus MA, Marroquin OC, Rao SV, Noveck H, Passano E, Hardison RM, Smitherman T, Vagaonescu T, Wimmer NJ, Williams DO. Liberal versus restrictive transfusion thresholds for patients with symptomatic coronary artery disease. Am Heart J. 2013 Jun;165(6):964-971.e1. doi: 10.1016/j.ahj.2013.03.001. Epub 2013 Apr 8.

Responsible Party:	Jeffrey L Carson, MD, Jeffrey L Carson, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:	NCT01167582 History of Changes
Other Study ID Numbers:	0220090205; 1RC2HL101458-01 ( U.S. NIH Grant/Contract )
First Posted:	July 22, 2010
Results First Posted:	August 28, 2014
Last Update Posted:	January 13, 2017
Last Verified:	November 2016

Keywords provided by Jeffrey L Carson, MD, Rutgers, The State University of New Jersey:

blood transfusion; red blood cell transfusion; myocardial infarction; acute coronary syndrome; anemia

Additional relevant MeSH terms:

Infarction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Myocardial Infarction; Ischemia; Angina, Unstable; Pathologic Processes; Necrosis; Heart Diseases	Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms