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Myocardial Ischemia and Transfusion Pilot (MINT Pilot)

Primary Purpose

Myocardial Infarction, Unstable Angina, Coronary Artery Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Red blood cell transfusion
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring blood transfusion, red blood cell transfusion, myocardial infarction, acute coronary syndrome, anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Brigham and Women's Hospital
  • Robert Wood Johnson University Hospital
  • Montefiore Medical Center
  • Jack D. Weiler Hospital of Montefiore Medical Center
  • University of Pittsburgh Medical Center
  • University of Pittsburgh Data Coordinating Center
  • Rhode Island Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Liberal Transfusion Strategy

Restrictive transfusion strategy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hemoglobin Concentration
Differences in the mean hemoglobin concentrations between the two study arms.
Red Blood Cell Transfusion
Differences in mean number of units of red blood cell transfusions between the two study arms.

Secondary Outcome Measures

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.
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.
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.
Mortality From Cardiac Causes
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.
Stroke
Congestive Heart Failure
Stent Thrombosis
Deep Vein Thrombosis or Pulmonary Embolism
Pneumonia or Blood Stream Infection and Each Separately
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.

Full Information

First Posted
March 17, 2010
Last Updated
March 10, 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
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1. Study Identification

Unique Protocol Identification Number
NCT01167582
Brief Title
Myocardial Ischemia and Transfusion Pilot
Acronym
MINT Pilot
Official Title
Myocardial Ischemia and Transfusion Pilot
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Unstable Angina, Coronary Artery Disease
Keywords
blood transfusion, red blood cell transfusion, myocardial infarction, acute coronary syndrome, anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liberal Transfusion Strategy
Arm Type
Experimental
Arm Description
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.
Arm Title
Restrictive transfusion strategy
Arm Type
Experimental
Arm Description
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 Type
Biological
Intervention Name(s)
Red blood cell transfusion
Intervention Description
Liberal versus restrictive transfusion
Primary Outcome Measure Information:
Title
Hemoglobin Concentration
Description
Differences in the mean hemoglobin concentrations between the two study arms.
Time Frame
In-hospital up to 30 days post randomization
Title
Red Blood Cell Transfusion
Description
Differences in mean number of units of red blood cell transfusions between the two study arms.
Time Frame
In-hospital up to 30 days post randomization
Secondary Outcome Measure Information:
Title
Mortality or Myocardial Ischemia
Description
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.
Time Frame
30 days
Title
Mortality or Myocardial Ischemia
Description
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.
Time Frame
6 months
Title
Individual Components of Composite Outcome
Description
All cause mortality Myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction) Unscheduled coronary revascularization.
Time Frame
30 days
Title
Mortality From Cardiac Causes
Time Frame
30 days
Title
Unscheduled Hospital Admission
Description
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.
Time Frame
30 days
Title
Stroke
Time Frame
30 days
Title
Congestive Heart Failure
Time Frame
30 days
Title
Stent Thrombosis
Time Frame
30 days
Title
Deep Vein Thrombosis or Pulmonary Embolism
Time Frame
30 days
Title
Pneumonia or Blood Stream Infection and Each Separately
Time Frame
30 days
Title
Composite Mortality and Morbidity
Description
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.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey L Carson, MD
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sheryl F Kelsey, PhD
Organizational Affiliation
University of Pittsburgh Data Coordinating Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02120
Country
United States
Facility Name
Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461-2301
Country
United States
Facility Name
Jack D. Weiler Hospital of Montefiore Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Pittsburgh Data Coordinating Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23708168
Citation
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.
Results Reference
result
PubMed Identifier
34932836
Citation
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.
Results Reference
derived

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Myocardial Ischemia and Transfusion Pilot

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