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Myocardial Ischemia and Transfusion Pilot (MINT Pilot)
This study has been completed.
Sponsor:
Rutgers, The State University of New Jersey
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
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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 Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Myocardial Ischemia and Transfusion Pilot |
Resource links provided by NLM:
Further study details as provided by Jeffrey L Carson, MD, Rutgers, The State University of New Jersey:
Primary Outcome Measures:
- Trial Feasibility [ Time Frame: 6 months ]
- the number of eligible study subjects and enrollment rates, overall and by center;
- the adherence rates for the transfusion protocol, overall and by center;
- 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.
Secondary Outcome Measures:
- 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.
| 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 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 (Adult, Senior) |
| 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
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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
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
National Heart, Lung, and Blood Institute (NHLBI)
University of Pittsburgh
Albert Einstein College of Medicine, Inc.
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: | Jeffrey L Carson, MD, Jeffrey L Carson, Rutgers, The State University of New Jersey |
| ClinicalTrials.gov Identifier: | NCT01167582 History of Changes |
| Other Study ID Numbers: |
0220090205 1RC2HL101458-01 ( U.S. NIH Grant/Contract ) |
| Study First Received: | March 17, 2010 |
| Results First Received: | August 14, 2014 |
| Last Updated: | November 28, 2016 |
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:
|
Infarction Coronary Artery Disease Myocardial Ischemia Coronary Disease Myocardial Infarction Ischemia Angina, Unstable Pathologic Processes Necrosis Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Angina Pectoris Chest Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on September 21, 2017