Myocardial InfarctionPhase 3MINT PilotNCT01167582

Myocardial Ischemia and Transfusion Pilot

A Phase 3 study testing Red blood cell transfusion in people with Myocardial Infarction and Unstable Angina, run by Rutgers, The State University of New Jersey at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Myocardial Infarction, Unstable Angina, Coronary Artery Disease
What is being tested?: Red blood cell transfusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 7 sitesUnited States
Study dates: Sep 2009to Jun 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 12Show fewer

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.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

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

Other trials in United States

About this study

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.

Conditions: Myocardial Infarction, Unstable Angina, Coronary Artery Disease
Being tested: Red blood cell transfusion
Keywords: blood transfusion, red blood cell transfusion, myocardial infarction, acute coronary syndrome, anemia
Medical subject headings: Myocardial Infarction, Angina, Unstable, Coronary Artery Disease, Acute Coronary Syndrome, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Red blood cell transfusionBiological
Liberal versus restrictive transfusion

Study groups in NCT01167582
Study group	Role	What they receive
Liberal Transfusion Strategy	Experimental	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. Receives: Biological: Red blood cell transfusion
Restrictive transfusion strategy	Experimental	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. Receives: Biological: Red blood cell transfusion

What is being measured

The primary outcome is the main question the study is designed to answer.

Hemoglobin Concentration
Differences in the mean hemoglobin concentrations between the two study arms.
Measured: In-hospital up to 30 days post randomization
Red Blood Cell Transfusion
Differences in mean number of units of red blood cell transfusions between the two study arms.
Measured: In-hospital up to 30 days post randomization

Secondary outcomes (11)

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.
Measured: 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.
Measured: 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.
Measured: 30 days
Mortality From Cardiac Causes
Measured: 30 days
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.
Measured: 30 days
Stroke
Measured: 30 days
Congestive Heart Failure
Measured: 30 days
Stent Thrombosis
Measured: 30 days
Deep Vein Thrombosis or Pulmonary Embolism
Measured: 30 days
Pneumonia or Blood Stream Infection and Each Separately
Measured: 30 days
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.
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009Jun 2012

First posted22 Jul 2010 (estimated)
Study startSep 2009
Primary completionJun 2012
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01167582
Sponsor's protocol ID: 0220090205
Other IDs: 1RC2HL101458-01
Acronym: MINT Pilot
Status last verified: Mar 2019
First submitted: 17 Mar 2010
Last updated: 20 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.
PubMed 41114449
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Myocardial Infarction trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Myocardial Ischemia and Transfusion Pilot
ClinicalTrials.gov ID: NCT01167582
Acronym / sponsor ID: MINT Pilot / 0220090205
Conditions: Myocardial Infarction, Unstable Angina, Coronary Artery Disease
Keywords: blood transfusion, red blood cell transfusion, myocardial infarction, acute coronary syndrome, anemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: Rutgers, The State University of New JerseyUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), University of Pittsburgh, Albert Einstein College of Medicine, Brigham and Women's Hospital, Rhode Island Hospital
Study start: Sep 2009
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 22 Jul 2010 (estimated)
Results: Posted 28 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Liberal Transfusion Strategy	Experimental	Biological: Red blood cell transfusionPatients 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.
Restrictive transfusion strategy	Experimental	Biological: Red blood cell transfusionReceive 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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);

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Red blood cell transfusionLiberal versus restrictive transfusion	Biological	Liberal Transfusion Strategy, Restrictive transfusion strategy

Primary outcome

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.

11 secondary outcomes

Mortality or Myocardial Ischemia
Time frame: 30 days
Mortality or Myocardial Ischemia
Time frame: 6 months
Individual Components of Composite Outcome
Time frame: 30 days
Mortality From Cardiac Causes
Time frame: 30 days
Unscheduled Hospital Admission
Time frame: 30 days
Stroke
Time frame: 30 days
Congestive Heart Failure
Time frame: 30 days
Stent Thrombosis
Time frame: 30 days
Deep Vein Thrombosis or Pulmonary Embolism
Time frame: 30 days
Pneumonia or Blood Stream Infection and Each Separately
Time frame: 30 days
Composite Mortality and Morbidity
Time frame: 30 days

Results and safety

Results posted to the registry on 28 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Liberal Transfusion Strategy	55	55
Restrictive Transfusion Strategy	55	54

Primary outcome: Hemoglobin Concentration

Time frame: In-hospital up to 30 days post randomization. Mean (Standard Deviation). Unit: g/dL

Measure	Liberal Transfusion Strategy n = 55	Restrictive Transfusion Strategy n = 55
Hemoglobin Day 1 Post Randomization	10.30 (1.00)	9.03 (0.82)
Hemoglobin Day 2 Post Randomization	10.78 (0.78)	8.98 (0.80)
Hemoglobin Day 3 Post Randomization	10.64 (0.71)	9.12 (0.75)

Liberal Transfusion Strategy vs Restrictive Transfusion Strategy: p <0.001, t-test, 2 sided
Liberal Transfusion Strategy vs Restrictive Transfusion Strategy: p <0.001, t-test, 2 sided
Liberal Transfusion Strategy vs Restrictive Transfusion Strategy: p <0.001, t-test, 2 sided

Primary outcome: Red Blood Cell Transfusion

Time frame: In-hospital up to 30 days post randomization. Mean (Standard Deviation). Unit: blood units

Measure	Liberal Transfusion Strategy n = 55	Restrictive Transfusion Strategy n = 55
Value	1.58 (1.13)	0.49 (1.03)

Liberal Transfusion Strategy vs Restrictive Transfusion Strategy: p <0.001, t-test, 2 sided

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 6 months following randomization. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Liberal Transfusion Strategy	7 of 55 (12.7%)	0 of 55 (0%)	Not reported
Restrictive Transfusion Strategy	10 of 54 (18.5%)	0 of 54 (0%)	Not reported

Limitations and caveats (from the sponsor): This pilot trial was not designed to enroll enough patients to answer the transfusion dilemma currently facing clinicians in practice.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23708168Carson 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.
Derived from this study: PubMed 41114449Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.
Derived from this study: PubMed 34932836Carson 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Red blood cell transfusion in people with Myocardial Infarction and Unstable Angina, run by Rutgers, The State University of New Jersey at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin Concentration (time frame: In-hospital up to 30 days post randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01167582, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.