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CompletedNCT01167582MINT PilotUpdated Mar 20, 2019Results posted

Myocardial Ischemia and Transfusion Pilot

A Phase 3 interventional study of Red blood cell transfusion in Myocardial Infarction, Unstable Angina and Coronary Artery Disease, sponsored by Rutgers, The State University of New Jersey. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-20.

Sponsored by Rutgers, The State University of New Jersey · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Myocardial Infarction
  • Unstable Angina
  • Coronary Artery Disease

Keywords

  • blood transfusion
  • red blood cell transfusion
  • myocardial infarction
  • acute coronary syndrome
  • anemia
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 110 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
110 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BiologicalRed blood cell transfusion

    Liberal versus restrictive transfusion

06

What researchers measure

Primary outcomes

  1. Hemoglobin Concentration

    Differences in the mean hemoglobin concentrations between the two study arms.

    Time frame: In-hospital up to 30 days post randomization

  2. Red Blood Cell Transfusion

    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 outcomes

  1. 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.

    Time frame: 30 days

  2. 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.

    Time frame: 6 months

  3. 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.

    Time frame: 30 days

  4. Mortality From Cardiac Causes

    Time frame: 30 days

  5. 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.

    Time frame: 30 days

  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

    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

07

Results

Posted Aug 28, 2014
Limitations and caveats
This pilot trial was not designed to enroll enough patients to answer the transfusion dilemma currently facing clinicians in practice.

Participant flow

Participant flow — Overall Study
MilestoneLiberal Transfusion StrategyRestrictive Transfusion Strategy
Started5555
Completed5554
Not completed01
Withdrew: Lost to follow-up01

Outcome measures

PrimaryHemoglobin Concentration

Differences in the mean hemoglobin concentrations between the two study arms.

Time frame:
In-hospital up to 30 days post randomization
Reported as:
Mean · g/dL
Hemoglobin Concentration
g/dLLiberal Transfusion StrategyRestrictive Transfusion Strategy
Hemoglobin Day 1 Post Randomization10.30 ± 1.009.03 ± 0.82
Hemoglobin Day 2 Post Randomization10.78 ± 0.788.98 ± 0.80
Hemoglobin Day 3 Post Randomization10.64 ± 0.719.12 ± 0.75
Statistical analysis
  • Liberal Transfusion Strategy vs Restrictive Transfusion Strategy · t-test, 2 sided · p = <0.001
  • Liberal Transfusion Strategy vs Restrictive Transfusion Strategy · t-test, 2 sided · p = <0.001
  • Liberal Transfusion Strategy vs Restrictive Transfusion Strategy · t-test, 2 sided · p = <0.001
PrimaryRed Blood Cell Transfusion

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
Reported as:
Mean · blood units
Red Blood Cell Transfusion
blood unitsLiberal Transfusion StrategyRestrictive Transfusion Strategy
Red Blood Cell Transfusion1.58 ± 1.130.49 ± 1.03
Statistical analysis
  • Liberal Transfusion Strategy vs Restrictive Transfusion Strategy · t-test, 2 sided · p = <0.001
SecondaryMortality 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.

Time frame:
30 days
Reported as:
Count of participants · Participants
Mortality or Myocardial Ischemia
ParticipantsLiberal Transfusion StrategyRestrictive Transfusion Strategy
Mortality or Myocardial Ischemia614
Statistical analysis
  • Liberal Transfusion Strategy vs Restrictive Transfusion Strategy · Risk ratio (rr): 2.38 · 95% CI 0.99 to 5.73Restrictive Arm (numerator) compared to Liberal Arm (denominator)
SecondaryMortality 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.

Time frame:
6 months
Reported as:
Count of participants · Participants
Mortality or Myocardial Ischemia
ParticipantsLiberal Transfusion StrategyRestrictive Transfusion Strategy
Mortality or Myocardial Ischemia1520
Statistical analysis
  • Liberal Transfusion Strategy vs Restrictive Transfusion Strategy · Risk difference (rd): 9.7 · 95% CI -5.3 to 24.7Restrictive Arm (numerator) compared to Liberal Arm (denominator)
SecondaryIndividual 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.

Time frame:
30 days
Reported as:
Count of participants · Participants
Individual Components of Composite Outcome
ParticipantsLiberal Transfusion StrategyRestrictive Transfusion Strategy
Mortality17
Myocardial Infarction57
Unscheduled Coronary Revascularization02
Statistical analysis
  • Liberal Transfusion Strategy vs Restrictive Transfusion Strategy · Risk ratio (rr): 7.13 · 95% CI 0.91 to 56.02Restrictive Arm (numerator) compared to Liberal Arm (denominator)
  • Liberal Transfusion Strategy · Risk ratio (rr): 1.43 · 95% CI 0.48 to 4.22Restrictive Arm (numerator) compared to Liberal Arm (denominator)
SecondaryMortality From Cardiac Causes
Time frame:
30 days
Reported as:
Count of participants · Participants
Mortality From Cardiac Causes
ParticipantsLiberal Transfusion StrategyRestrictive Transfusion Strategy
Mortality From Cardiac Causes17
SecondaryUnscheduled 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.

Time frame:
30 days
Reported as:
Count of participants · Participants
Unscheduled Hospital Admission
ParticipantsLiberal Transfusion StrategyRestrictive Transfusion Strategy
Any Readmission917
Cardiac Readmission38
Infection Readmission02
SecondaryStroke
Time frame:
30 days
Reported as:
Count of participants · Participants
Stroke
ParticipantsLiberal Transfusion StrategyRestrictive Transfusion Strategy
Stroke10
SecondaryCongestive Heart Failure
Time frame:
30 days
Reported as:
Count of participants · Participants
Congestive Heart Failure
ParticipantsLiberal Transfusion StrategyRestrictive Transfusion Strategy
Congestive Heart Failure27
SecondaryStent Thrombosis
Time frame:
30 days
Reported as:
Count of participants · Participants
Stent Thrombosis
ParticipantsLiberal Transfusion StrategyRestrictive Transfusion Strategy
Stent Thrombosis00
SecondaryDeep Vein Thrombosis or Pulmonary Embolism
Time frame:
30 days
Reported as:
Count of participants · Participants
Deep Vein Thrombosis or Pulmonary Embolism
ParticipantsLiberal Transfusion StrategyRestrictive Transfusion Strategy
Deep Vein Thrombosis or Pulmonary Embolism10
SecondaryPneumonia or Blood Stream Infection and Each Separately
Time frame:
30 days
Reported as:
Count of participants · Participants
Pneumonia or Blood Stream Infection and Each Separately
ParticipantsLiberal Transfusion StrategyRestrictive Transfusion Strategy
Pneumonia or Blood Stream Infection02
Pneumonia02
Blood Stream Infection00
SecondaryComposite 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.

Time frame:
30 days
Reported as:
Count of participants · Participants
Composite Mortality and Morbidity
ParticipantsLiberal Transfusion StrategyRestrictive Transfusion Strategy
Composite Mortality and Morbidity616

Adverse events

Collected over Up to 6 months following randomization. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Liberal Transfusion Strategy—7/55 (12.7%)0/55 (0%)
Restrictive Transfusion Strategy—10/54 (18.5%)0/54 (0%)
Most frequent serious events
Most frequent serious events
EventLiberal Transfusion StrategyRestrictive Transfusion Strategy
Death at 6 monthsCardiac disorders7/5510/54
Myocardial Infarction at 30 daysCardiac disorders5/557/54
Congestive Heart Failure at 30 DaysCardiac disorders2/557/54

Baseline characteristics

Randomized patients

Age, Continuous
Age, Continuous(years)Liberal Transfusion StrategyRestrictive Transfusion StrategyTotal
Mean67.3 ± 13.674.3 ± 11.170.8 ± 12.8
Sex: Female, Male
Sex: Female, Male(Participants)Liberal Transfusion StrategyRestrictive Transfusion StrategyTotal
Female272855
Male282755
08

Study locations

7 sites
  • Brigham and Women's Hospital
    Boston, Massachusetts 02120, United States
  • Robert Wood Johnson University Hospital
    New Brunswick, New Jersey 08903, United States
  • Montefiore Medical Center
    Bronx, New York 10461-2301, United States
  • Jack D. Weiler Hospital of Montefiore Medical Center
    New York, New York 10461, United States
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania 15213, United States
  • University of Pittsburgh Data Coordinating Center
    Pittsburgh, Pennsylvania 15261, United States
  • Rhode Island Hospital
    Providence, Rhode Island 02903, United States
09

References and documents

Publications

  • 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. PubMed 23708168 ↗
  • 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. PubMed 34932836 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01167582
Lead 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
Responsible party
Jeffrey L Carson, MD (Jeffrey L Carson, Rutgers, The State University of New Jersey) — Principal investigator
First posted
Jul 22, 2010
Start date
Sep 2009
Primary completion
Jun 2012
Completion
Jun 2012
Results posted
Aug 28, 2014
Last update
Mar 20, 2019

Study contacts

Jeffrey L Carson, MD
study chair · Rutgers, The State University of New Jersey
Sheryl F Kelsey, PhD
principal investigator · University of Pittsburgh Data Coordinating Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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