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Myocardial Ischemia and Transfusion Pilot (MINT Pilot)

This study has been completed.
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
University of Pittsburgh
Albert Einstein College of Medicine, Inc.
Brigham and Women's Hospital
Rhode Island Hospital
Information provided by (Responsible Party):
Jeffrey L Carson, MD, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01167582
First received: March 17, 2010
Last updated: November 28, 2016
Last verified: November 2016
March 17, 2010
November 28, 2016
September 2009
June 2012   (Final data collection date for primary outcome measure)
  • 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
  • Hemoglobin Concentration [ Time Frame: In-hospital up to 30 days post randomization ]
    Differences in the mean hemoglobin concentrations between the two study arms.
  • 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.
  • Trial performance and 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
  • Hemoglobin Concentration [ Time Frame: In-hospital up to 30 days post randomization ]
    We will compare the mean hemoglobin concentrations and mean (or median) number of units of red blood cell transfusions between the two study arms.
Complete list of historical versions of study NCT01167582 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • 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.
  • Mortality From Cardiac Causes [ Time Frame: 30 days and 6 months ]
  • 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.
  • Stroke [ Time Frame: 30 days and 6 months ]
  • Congestive Heart Failure [ Time Frame: 30 days and 6 months ]
  • Stent Thrombosis [ Time Frame: 30 days and 6 months ]
  • Deep Vein Thrombosis and Pulmonary Embolism [ Time Frame: 30 days and 6 months ]
  • Pneumonia or Blood Stream Infection and Each Separately [ Time Frame: 30 days and 6 months ]
  • 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.
Same as current
Not Provided
Not Provided
 
Myocardial Ischemia and Transfusion Pilot
Myocardial Ischemia and Transfusion Pilot
The purpose of this study is to evaluate two approaches to red blood cell transfusion in anemic patients with acute coronary syndrome.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Myocardial Infarction
  • Unstable Angina
  • Coronary Artery Disease
Biological: Red blood cell transfusion
Liberal versus restrictive transfusion
  • 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.
    Intervention: Biological: Red blood cell 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.

    Intervention: Biological: Red blood cell transfusion
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
June 2012
June 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01167582
0220090205
1RC2HL101458-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Jeffrey L Carson, MD, Rutgers, The State University of New Jersey
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
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
Rutgers, The State University of New Jersey
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP