Myocardial Ischemia and Transfusion Pilot (MINT Pilot)

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

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Coronary Artery Disease; Unstable Angina
• Intervention / Treatment: Biological: Red blood cell 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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin Concentration	Differences in the mean hemoglobin concentrations between the two study arms.	In-hospital up to 30 days post randomization
Red Blood Cell Transfusion	Differences in mean number of units of red blood cell transfusions between the two study arms.	In-hospital up to 30 days post randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke		30 days
Mortality or Myocardial Ischemia	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.	30 days
Mortality or Myocardial Ischemia	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.	6 months
Individual Components of Composite Outcome	All cause mortality Myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction) Unscheduled coronary revascularization.	30 days
Mortality From Cardiac Causes		30 days
Unscheduled Hospital Admission	Unscheduled hospital admission at 30 days for any reason, for cardiac reason (e.g., acute coronary syndrome, MI, congestive heart failure, or arrhythmia), or infection.	30 days
Congestive Heart Failure		30 days
Stent Thrombosis		30 days
Deep Vein Thrombosis or Pulmonary Embolism		30 days
Pneumonia or Blood Stream Infection and Each Separately		30 days
Composite Mortality and Morbidity	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 or pneumonia.	30 days

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Albert Einstein College of Medicine; University of Pittsburgh; 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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: March 17, 2010
• First Submitted That Met QC Criteria: July 21, 2010
• First Posted (Estimate): July 22, 2010

Study Record Updates

• Last Update Posted (Actual): March 20, 2019
• Last Update Submitted That Met QC Criteria: March 10, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: acute coronary syndrome; myocardial infarction; anemia; blood transfusion; red blood cell transfusion
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Coronary Disease; Chest Pain; Angina Pectoris; Myocardial Infarction; Infarction; Coronary Artery Disease; Myocardial Ischemia; Ischemia; Angina, Unstable
• Other Study ID Numbers: 0220090205; 1RC2HL101458-01 (U.S. NIH Grant/Contract)