Myocardial Ischemia and Transfusion Pilot (MINT Pilot)

• ClinicalTrials.gov Identifier: NCT01167582
• Recruitment Status: Completed
• First Posted: July 22, 2010
• Results First Posted: August 28, 2014
• Last Update Posted: March 20, 2019
• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); University of Pittsburgh; Albert Einstein College of Medicine; Brigham and Women's Hospital; Rhode Island Hospital
• Information provided by (Responsible Party): Jeffrey L Carson, MD, Rutgers, The State University of New Jersey

Study Description

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

• 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

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

Primary Outcome Measures :

1. Hemoglobin Concentration [ Time Frame: In-hospital up to 30 days post randomization ]
   Differences in the mean hemoglobin concentrations between the two study arms.
2. 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 ]
   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 ]
5. Unscheduled Hospital Admission [ Time Frame: 30 days ]
   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.
6. Stroke [ Time Frame: 30 days ]
7. Congestive Heart Failure [ Time Frame: 30 days ]
8. Stent Thrombosis [ Time Frame: 30 days ]
9. Deep Vein Thrombosis or Pulmonary Embolism [ Time Frame: 30 days ]
10. Pneumonia or Blood Stream Infection and Each Separately [ Time Frame: 30 days ]
11. Composite Mortality and Morbidity [ Time Frame: 30 days ]
    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.

Eligibility Criteria

• 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

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

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 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Dorée C, Hébert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12:CD002042. doi: 10.1002/14651858.CD002042.pub5. Review.

• Responsible Party: Jeffrey L Carson, MD, Jeffrey L Carson, Rutgers, The State University of New Jersey
• ClinicalTrials.gov Identifier: NCT01167582
• 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: March 20, 2019
• Last Verified: March 2019

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:

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