Myocardial Ischemia and Transfusion (MINT)

This study has been completed.
Sponsor:
Collaborators:
University of Pittsburgh
Albert Einstein College of Medicine of Yeshiva University
Brigham and Women's Hospital
Rhode Island Hospital
Information provided by (Responsible Party):
rwjmsmedicine, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01167582
First received: March 17, 2010
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Myocardial Infarction
Unstable Angina
Coronary Artery Disease
Biological: Red blood cell transfusion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Myocardial Ischemia and Transfusion

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Trial feasibility [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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

  • Hemoglobin concentration [ Time Frame: In-hospital up to 30 days post randomization ] [ Designated as safety issue: No ]
    We will compare the mean hemoglobin concentrations and mean (or median) number of units of red blood cell transfusions between the two study arms.


Secondary Outcome Measures:
  • Mortality or myocardial ischemia [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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.

  • Mortality or myocardial ischemia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Individual components of composite outcome [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: No ]
    All cause mortality Myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction) Unscheduled coronary revascularization.

  • Mortality from cardiac causes [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: No ]
  • Unscheduled hospital admission [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: No ]
    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.

  • Stroke [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: No ]
  • Congestive heart failure [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: No ]
  • Stent thrombosis [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: No ]
  • Deep vein thrombosis and pulmonary embolism [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: No ]
  • Pneumonia or blood stream infection and each separately [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: No ]
  • Composite mortality and morbidity [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 110
Study Start Date: September 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liberal Transfusion Strategy
Patients randomly allocated to the liberal transfusion strategy will 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01167582

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
University of Pittsburgh
Albert Einstein College of Medicine of Yeshiva University
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

Publications:
Responsible Party: rwjmsmedicine, Jeffrey L Carson, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01167582     History of Changes
Other Study ID Numbers: 0220090205, 1RC2HL101458-01
Study First Received: March 17, 2010
Last Updated: November 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
blood transfusion
red blood cell transfusion
myocardial infarction
acute coronary syndrome
anemia

Additional relevant MeSH terms:
Angina, Unstable
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Infarction
Ischemia
Myocardial Infarction
Angina Pectoris
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on August 26, 2014