Myocardial Ischemia and Transfusion Pilot

Coronary Artery Disease Clinical Trial

— MINT Pilot  

Official title:

Myocardial Ischemia and Transfusion Pilot

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01167582
• Other study ID #: 0220090205
• Secondary ID: 1RC2HL101458-01
• Status: Completed
• Phase: Phase 3
• Start date: September 2009
• Est. completion date: June 2012

Study information

• Verified date: March 2019
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Angina, Unstable
• Coronary Artery Disease
• Coronary Disease
• Infarction
• Ischemia
• Myocardial Infarction
• Myocardial Ischemia
• Unstable Angina

Intervention

Biological:
• Red blood cell transfusion
Liberal versus restrictive transfusion

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Robert Wood Johnson University Hospital	New Brunswick	New Jersey
United States	Jack D. Weiler Hospital of Montefiore Medical Center	New York	New York
United States	University of Pittsburgh Data Coordinating Center	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (6)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Albert Einstein College of Medicine, Brigham and Women's Hospital, National Heart, Lung, and Blood Institute (NHLBI), Rhode Island Hospital, University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 p — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin Concentration	Differences in the mean hemoglobin concentrations between the two study arms.	In-hospital up to 30 days post randomization
Primary	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	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
Secondary	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
Secondary	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
Secondary	Mortality From Cardiac Causes		30 days
Secondary	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
Secondary	Stroke		30 days
Secondary	Congestive Heart Failure		30 days
Secondary	Stent Thrombosis		30 days
Secondary	Deep Vein Thrombosis or Pulmonary Embolism		30 days
Secondary	Pneumonia or Blood Stream Infection and Each Separately		30 days
Secondary	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