Myocardial InfarctionPhase 3MINTNCT02981407
Myocardial Ischemia and Transfusion
A Phase 3 study testing Red Blood Cell Transfusion in people with Myocardial Infarction and Anemia, run by Rutgers, The State University of New Jersey at 133 sites in 6 countries.
Trial summary
The purpose of this study is to compare two red blood cell transfusion strategies (liberal and restrictive) for patients who have had an acute myocardial infarction and are anemic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Anemia
- What is being tested?
- Red Blood Cell Transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,506 participants
- Where
- 133 sitesin 6 countries
- Study dates
- 25 Apr 2017to 20 Oct 2023
- 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
- 18 years of age or older
- Either ST segment elevation myocardial infarction or Non ST segment elevation myocardial infarction consistent with the 3rd Universal Definition of Myocardial Infarction criteria that occurs on admission or during the index hospitalization
- Hemoglobin concentration less than 10 g/dL at the time of random allocation
- Patient physician believes that both of the transfusion strategies are consistent with good medical care for the patient
Who cannot join
- Uncontrolled acute bleeding at the time of randomization defined as the need for uncrossed or non-type specific blood
- Decline blood transfusion
- Scheduled for cardiac surgery during the current admission
- Receiving only palliative treatment
- Known that follow-up will not be possible at 30 days
- Previously participated in MINT
- Currently enrolled in a competing study that interferes with the intervention or follow-up of MINT or enrolled in a competing study that has not been approved by the local Institutional Review Board
- Patient physician does not believe the patient is an appropriate candidate for the trial
Trial locations and contacts
133 sites in 6 countries.
133 sites in 6 countries
United States60 sites
Albany Medical College
Albany, New York, 12208
University of New Mexico
Albuquerque, New Mexico, 87131
University of Michigan
Ann Arbor, Michigan, 48109
Southside Hospital
Bay Shore, New York, 11706
Massachusetts General Hospital
Boston, Massachusetts, 01930
Boston Medical Center
Boston, Massachusetts, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 15261
NYP Brooklyn Methodist
Brooklyn, New York, 11215
Lahey Hospital
Burlington, Massachusetts, 01805
University of Vermont Medical Center
Burlington, Vermont, 05401
Copper University Hospital
Camden, New Jersey, 08103
Aultman Hospital
Canton, Ohio, 44710
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7097
Rush University Medical Center
Chicago, Illinois, 60612
University of Chicago Medical Center
Chicago, Illinois, 60637
Danbury Hospital
Danbury, Connecticut, 06810
Essentia Health
Duluth, Minnesota, 55805
Durham Va
Durham, North Carolina, 27705
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007
New York Presbyterian/Queens
Flushing, New York, 11355
Greenville Health System
Greenville, South Carolina, 29605
Memorial Hospital at Gulfport
Gulfport, Mississippi, 39502
Hackensacjk University Medical Center
Hackensack, New Jersey, 07601
Westchester Medical Center
Hawthorne, New York, 10532
AMITA Health
Hinsdale, Illinois, 60521
Baylor St Luke's Medical Center
Houston, Texas, 77030
Saint Luke's Mid America Heart
Kansas City, Kansas, 64111
Lancaster General Hospital
Lancaster, Pennsylvania, 17602
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, 72205
University of Arkansas Medical Sciences (UAMS) Hospital
Little Rock, Arkansas, 72205
VAGLAHS
Los Angeles, California, 90073
University of Louisville
Louisville, Kentucky, 40202
North Shore University Hospital
Manhasset, New York, 11030
The Memphis VAMC
Memphis, Tennessee, 38104
Medical College of Wisconsin - Froedtert Hospital
Milwaukee, Wisconsin, 53226
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, 55105
Minneapolis Heart Institute (Foundation)
Minneapolis, Minnesota, 55407-1130
Northern Westchester Hospital
Mount Kisco, New York, 10549
Jersey Shore University Medical
Neptune City, New Jersey, 08759
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
Tulane University School of Medicine
New Orleans, Louisiana, 70112
NYU Langone Medical Center, Bellevue Hospital
New York, New York, 10016
Lenox Hilll Hospital
New York, New York, 10075
PENN Presbyterian Medical Cente
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15261
Rhode Island Hospital
Providence, Rhode Island, 02903
The Miriam Hospital
Providence, Rhode Island, 02906
WakeMed Health and Hospital
Raleigh, North Carolina, 27610
Virginia Commonwealth University
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55905
Rochester General Hospital
Rochester, New York, 14450
University of Rochester
Rochester, New York, 14642
Washington University
St Louis, Missouri, 63110
Northwell Staten Island Hopsital
Staten Island, New York, 10305
Stony Brook Medicine
Stony Brook, New York, 11794-8167
Montefiore Medical Center
The Bronx, New York, 10467
University of Toledo Medical Center
Toledo, Ohio, 43614
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
St. Joseph Mercy Health System
Ypsilanti, Michigan, 48197
Canada27 sites
Foothills Medical Centre
Calgary, Alberta
Grey Nuns Community Hospital
Edmonton, Alberta
Royal Alexandra Hospital
Edmonton, Alberta
University of Alberta Hospital
Edmonton, Alberta
Hôpital Charles Lemoyne
Greenfield Park, Quebec
QE II Health Sciences Center
Halifax, Nova Scotia
Hamilton Health Sciences
Hamilton, Ontario
Hamilton St. Joseph's Health
Hamilton, Ontario
St. Joseph's Health Centre
Hamilton, Ontario
Hotel-Dieu de Levis
Lévis, Quebec
University Hospital - LHSC
London, Ontario
Victoria Hospital - LHSC
London, Ontario
Centre Hosp. Universitaire de Montréal
Montreal, Quebec
Jewish General Hospital
Montreal, Quebec
Montreal General Hospital
Montreal, Quebec
Royal Victoria Hospital
Montreal, Quebec
Royal Columbian Hospital
New Westminster, British Columbia
Quebec Heart and Lung Institute
Québec, Quebec
Regina General Hospital
Regina, Saskatchewan
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec
Surrey Memorial Hospital
Surrey, British Columbia
St. Michael's Hospital
Toronto, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario
General Hospital Trois-Rivièrs
Trois-Rivières, Quebec
Vancouver General Hospital
Vancouver, British Columbia
Victoria Heart Institute
Victoria, Ontario
St. Boniface General Hospital
Winnipeg, Manitoba
Brazil18 sites
Hospital Felício Rocho
Belo Horizonte
Instituto Orizonti
Belo Horizonte
Instituto de Ensino e Pesquisa do Hospital do Coração do Brasil
Brasília
Hospital Vera Cruz
Campinas
Santa Casa de Marília
Cascata, 17515-900
Sociedade Hospitalar Angelina Caron
Centro, 83430-000
Instituto de Ensino e Pesquisa do Hospital da Bahia
Pituba, Salvador, 41810
Hospital Maternidade e Pronto Socorro Santa Lúcia
Poços de Caldas
Instituto de Cardiologia do RS
Porto Alegre
Hospital Agamenon Magalhães
Recife
Pronto Socorro Cardiológico de Pernambuco Prof. Luiz Tavares- PROCAPE
Recife
Hospital Cárdio Pulmonar
Salvador
Hospital Universitário Professor Edgard Santos
Salvador
Hospital de Base de Rio Preto
São José do Rio Preto, São Paulo, 15080-310
Hospital de Base de Rio Preto
São José do Rio Preto
Hospital São Paulo
São Paulo, 04024-002
Hospital de Clínicas da UFTM
Uberaba
Hospital das Clinicas da UFU
Uberlândia
France18 sites
CHRU Tours -Hôpital Trousseau
Chambray-lès-Tours
CH Chartres - Chartres
Chartres
Centre Hospitalier Sud Francilien
Corbeil-Essonnes
CHU le Bocage - Dijon
Dijon, 21079
La Tronche Hôpital Michallon
La Tronche
Centre Hospitalier Universitaire de Lille
Lille, 59000
CHU Arnaud de Villeneuve - Montpellier
Montpellier
CHU Nancy
Nancy
Hôpital Pasteur
Nice, 06000
Hôpital Universitaire Carémeau (CHU Carémeau)
Nîmes, 30029
Hôpital La Pitié Salpétrière
Paris, 75013
Hôpital Européen Georges-Pompidou
Paris, 75015
Hôpital BICHAT- APHP
Paris, 75018
Hôpital Lariboisière
Paris
Hôpital Haut Lévêque
Pessac, 33604
CHU Poitiers - Poitiers
Poitiers
Hôpital Charles Nicolle- Rouen
Rouen
Hôpital Rangueil
Toulouse, 31400
New Zealand6 sites
Auckland City Hospital
Auckland
Christchurch Hospital
Christchurch
Gisborne Hospital
Gisborne
Nelson Hospital
Nelson
Taranaki Hospital
New Plymouth
Whangarei Hospital
Whangarei
Australia4 sites
Flinders Medical Centre
Bedford Park
Concord Repatriation General Hospital
Concord
Gosford Hospital
Gosford
Royal Perth Hospital
Perth
About this study
The purpose of this study is to compare two red blood cell transfusion strategies (liberal and restrictive) for patients who have had an acute myocardial infarction and are anemic.
Read the detailed description
In most clinical settings, evidence suggests it is safe to wait to give a blood transfusion. However, for those who have suffered a heart attack, there is a lack of high quality evidence to guide transfusions. This 3500 subject multi-center randomized trial will fill that void.
Hospital inpatients diagnosed with myocardial infarction who have blood counts less than 10 g/dL are randomized to receive either a liberal or a restrictive transfusion strategy.
Patients randomized to the liberal transfusion strategy will receive a red blood cell transfusion anytime there is a blood count of less than 10 g/dL.
Patients randomized to the restrictive transfusion strategy are permitted to receive a blood transfusion if the blood count is below 8 g/dL and the physician believes it is in the patient's best interest. A transfusion will be strongly recommended if the blood count drops to less than 7 g/dL. If the patient has symptoms of angina (e.g., chest discomfort described as pressure or heaviness) that do not go away with medication, a blood transfusion is ordered regardless of the blood count.
The transfusions strategies will be maintained until hospital discharge for a maximum of 30 days.
Patients will be followed for 30 days for clinically relevant outcomes. Vital status will be confirmed at 180 days.
- Conditions
- Myocardial Infarction, Anemia
- Being tested
- Red Blood Cell Transfusion
- Keywords
- Red Blood Cell Transfusion, Anemia, Heart Disease, Cardiovascular Disease
- Medical subject headings
- Myocardial Infarction, Anemia, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red Blood Cell TransfusionBiological
Transfusion of packed red blood cell units
| Study group | Role | What they receive |
|---|---|---|
| Liberal Transfusion Strategy | Active comparator | Red blood cell transfusion - One unit of packed red cells is transfused following randomization followed by enough red blood cell units 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. Receives: Biological: Red Blood Cell Transfusion |
| Restrictive Transfusion Strategy | Active comparator | Permitted to receive a red blood cell transfusion if the blood count is below 8 g/dL and the physician believes it is in the patient's best interest. A transfusion will be strongly recommended if the blood count drops to less than 7 g/dL. If the patient has symptoms of angina (e.g., chest discomfort described as pressure or heaviness) that do not go away with medication, a blood transfusion will be ordered regardless of the blood count. Receives: Biological: Red Blood Cell Transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With All-cause Mortality or Nonfatal Myocardial Reinfarction
Measured: Within 30 days of randomization
Secondary outcomes (3)
All-cause Mortality
Measured: Within 30 days of randomization
Myocardial Reinfarction
Measured: Within 30 days of randomization
Composite of All-cause Mortality, Nonfatal Myocardial Reinfarction, Ischemia Driven Unscheduled Coronary Revascularization, or Readmission to the Hospital for Ischemic Cardiac Diagnosis
Measured: Within 30 days of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study start25 Apr 2017
- Primary completion31 May 2023
- Study completion20 Oct 2023
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 (21)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
- 3,506 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey L Carson, MD, Rutgers, The State University of New Jersey
- Investigators
- Jeffrey L Carson, MD, Principal investigator, Rutgers Robert Wood Johnson Medical SchoolMaria Mori Brooks, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981407
- Sponsor's protocol ID
- Pro20160000722
- Other IDs
- 1U01HL133817-01
- Acronym
- MINT
- Status last verified
- Apr 2024
- First submitted
- 1 Dec 2016
- Last updated
- 9 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Limited access data (i.e., records without personal identifiers) will be prepared by the Data Coordinating Center (DCC) and sent to the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) within 3 years after the end of the final patient follow-up or 2 years after the main paper of the trial has been published, whichever comes first. The Trial data set will include baseline patient characteristics, follow-up status, and clinical outcome data. The data will be released to requesting institutions and investigators in accordance with BioLINCC policy.
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 23708168Carson JL, Guyatt G, Heddle NM, Grossman BJ, Cohn CS, Fung MK, Gernsheimer T, Holcomb JB, Kaplan LJ, Katz LM, Peterson N, Ramsey G, Rao SV, Roback JD, Shander A, Tobian AA. Clinical Practice Guidelines From the AABB: Red Blood Cell Transfusion Thresholds and Storage. JAMA. 2016 Nov 15;316(19):2025-2035. doi: 10.1001/jama.2016.9185.
PubMed 27732721Carson JL, Brooks MM, Chaitman BR, Alexander JH, Goodman SG, Bertolet M, Abbott JD, Cooper HA, Rao SV, Triulzi DJ, Fergusson DA, Kostis WJ, Noveck H, Simon T, Steg PG, DeFilippis AP, Goldsweig AM, Lopes RD, White H, Alsweiler C, Morton E, Hebert PC; MINT Investigators. Rationale and design for the myocardial ischemia and transfusion (MINT) randomized clinical trial. Am Heart J. 2023 Mar;257:120-129. doi: 10.1016/j.ahj.2022.11.015. Epub 2022 Nov 20.
PubMed 36417955Carson JL, Brooks MM, Hebert PC, Goodman SG, Bertolet M, Glynn SA, Chaitman BR, Simon T, Lopes RD, Goldsweig AM, DeFilippis AP, Abbott JD, Potter BJ, Carrier FM, Rao SV, Cooper HA, Ghafghazi S, Fergusson DA, Kostis WJ, Noveck H, Kim S, Tessalee M, Ducrocq G, de Barros E Silva PGM, Triulzi DJ, Alsweiler C, Menegus MA, Neary JD, Uhl L, Strom JB, Fordyce CB, Ferrari E, Silvain J, Wood FO, Daneault B, Polonsky TS, Senaratne M, Puymirat E, Bouleti C, Lattuca B, White HD, Kelsey SF, Steg PG, Alexander JH; MINT Investigators. Restrictive or Liberal Transfusion Strategy in Myocardial Infarction and Anemia. N Engl J Med. 2023 Dec 28;389(26):2446-2456. doi: 10.1056/NEJMoa2307983. Epub 2023 Nov 11.
PubMed 37952133Kim S, Bertolet M, Chaitman BR, Alexander JH, Steg PG, Lopes RD, Simon T, Goodman SG, Strom JB, de Barros E Silva PGM, Ducrocq G, DeFilippis AP, Brooks MM, Carson J; MINT Trial investigators. Recurrent myocardial infarction identified by centralized troponin review: Insights from the MINT trial. Am Heart J. 2026 Aug 9:107553. doi: 10.1016/j.ahj.2026.107553. Online ahead of print.
PubMed 42571785Bertolet M, Carrier FM, Glynn S, Abbott JD, Defilippis AP, Simon T, Fordyce CB, Senaratne J, Potter BJ, Herbert BM, Rao SV, Caixeta A, Tessalee M, Cooper HA, Beraldo de Andrade P, Dall'Orto FTC, Silvain J, Carson JL, Brooks MM; Myocardial Ischemia and Transfusion (MINT) Trial Investigators. Restrictive vs Liberal Transfusion Strategy After Myocardial Infarction: A Post Hoc Analysis of the MINT Randomized Clinical Trial. JAMA Netw Open. 2026 Jul 1;9(7):e2624991. doi: 10.1001/jamanetworkopen.2026.24991.
PubMed 42507445DeFilippis AP, Abbott JD, Herbert BM, Bertolet MH, Chaitman BR, White HD, Goldsweig AM, Polonsky TS, Gupta R, Alsweiler C, Silvain J, de Barros E Silva PGM, Hillis GS, Daneault B, Tessalee M, Menegus MA, Rao SV, Lopes RD, Hebert PC, Alexander JH, Brooks MM, Carson JL, Goodman SG; MINT Investigators. The Effect of Restrictive vs Liberal Blood Transfusion Strategy on Subsequent Myocardial Infarction Type. JACC Adv. 2026 Jun;5(6 Pt 2):102836. doi: 10.1016/j.jacadv.2026.102836.
PubMed 42312774Cooper HA, Fordyce CB, Herbert BM, Alexander JH, Rao SV, Brooks MM, Bertolet M, Carson JL, Hebert PC; Myocardial Ischemia and Transfusion (MINT) Trial Investigators. Red Cell Transfusion in Critically Ill and Noncritically Ill Patients With Acute Myocardial Infarction and Anemia-A Subanalysis of the Myocardial Ischemia and Transfusion (MINT) Trial. Crit Care Med. 2026 Sep 1;54(9):2430-2435. doi: 10.1097/CCM.0000000000007211. Epub 2026 May 27.
PubMed 42188994Abbott JD, Benatar JR, Ballantyne CM, Jacobs AK, Goldsweig AM, Fergusson DA, Hebert BM, Bertolet M, Simon T, Steg PG, Goodman SG, White HD, Carson JL, Brooks MM; MINT Investigators. Comparative Efficacy of Transfusion Strategies in Women and Men With Myocardial Infarction and Anemia: Prespecified Secondary Findings From the MINT Trial. Circulation. 2026 Jul 21;154(3):201-211. doi: 10.1161/CIRCULATIONAHA.125.078320. Epub 2026 May 18.
PubMed 42145087Goldsweig AM, Ballantyne CM, White HD, Abbott JD, Fergusson DA, Herbert BM, Goodman SG, Carson JL, Brooks MM; MINT Investigators. Effect of age on restrictive and liberal transfusion outcomes in patients with anemia and myocardial infarction. Am Heart J. 2026 Jul;297:107381. doi: 10.1016/j.ahj.2026.107381. Epub 2026 Feb 19.
PubMed 41722885Carson 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 41114449Prochaska MT, Portela GT, Brooks MM, Fergusson DA, Hebert PC, Polonsky TS, Caixeta A, Cooper HA, Crozier I, Daneault B, Kim S, Bainey KR, de Barros E Silva P, Goldfarb M, Gupta R, Rao SV, Fonteles Ritt LE, Simon T, Carson JL. Transfusion Strategy Effect on Quality of Life in Patients With Myocardial Infarction and Anemia: A Secondary Analysis of the MINT Randomized Clinical Trial. JAMA Intern Med. 2025 Aug 1;185(8):947-954. doi: 10.1001/jamainternmed.2025.0654.
PubMed 40459491Rao SV, Brooks MM, D'Agostino HEA, Steg PG, Simon T, Aronow HD, Goldsweig AM, Malik S, Alsweiler C, Ho KKL, Dehghani P, Caixeta A, Quraishi AR, Robinson S, Traverse JH, Siddiqi O, Fergusson DA, Potter BJ, Schulman-Marcus J, Keating FK, Carson JL; MINT Trial Investigators. Effect of Red Blood Cell Transfusion Strategy on Clinical Outcomes Among Patients With Acute Myocardial Infarction Undergoing Revascularization: A Prespecified Analysis of the MINT Trial. Circ Cardiovasc Interv. 2025 May;18(5):e015249. doi: 10.1161/CIRCINTERVENTIONS.125.015249. Epub 2025 Mar 30.
PubMed 40159118Goldsweig AM, Kostis WJ, Herbert BM, Bouleti C, Potter BJ, Strom JB, Benatar J, Huynh T, Vallurupalli S, Figueiredo EL, Abbott JD, Cooper HA, DeFilippis AP, Fergusson DA, Goodman SG, Hebert PC, Lopes RD, Rao SV, Simon T, Carson JL, Brooks MM, Alexander JH; MINT Investigators. Blood Transfusion in Patients With Acute Myocardial Infarction, Anemia, and Heart Failure: Lessons From MINT. Circ Heart Fail. 2025 Apr;18(4):e012495. doi: 10.1161/CIRCHEARTFAILURE.124.012495. Epub 2025 Mar 26.
PubMed 40135329Portela GT, Ducrocq G, Bertolet M, Alexander JH, Goodman SG, Glynn S, Strom JB, Swanson SA, Lemesle G, Rao SV, Tessalee M, Polonsky TS, Goldfarb M, Traverse JH, Uhl L, Herbert BM, Silvain J, Carson JL, Brooks MM; MINT Trial Investigators. Individualized transfusion decisions to minimize adverse cardiovascular outcomes in patients with acute myocardial infarction and anemia. Am Heart J. 2025 Apr;282:146-155. doi: 10.1016/j.ahj.2025.01.009. Epub 2025 Jan 17.
PubMed 39826701
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Ischemia and Transfusion
- ClinicalTrials.gov ID
- NCT02981407
- Acronym / sponsor ID
- MINT / Pro20160000722
- Conditions
- Myocardial Infarction, Anemia
- Keywords
- Red Blood Cell Transfusion, Anemia, Heart Disease, Cardiovascular Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,506 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- University of Pittsburgh, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Posted 9 May 2024
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 compare two red blood cell transfusion strategies (liberal and restrictive) for patients who have had an acute myocardial infarction and are anemic.
Detailed description
In most clinical settings, evidence suggests it is safe to wait to give a blood transfusion. However, for those who have suffered a heart attack, there is a lack of high quality evidence to guide transfusions. This 3500 subject multi-center randomized trial will fill that void.
Hospital inpatients diagnosed with myocardial infarction who have blood counts less than 10 g/dL are randomized to receive either a liberal or a restrictive transfusion strategy.
Patients randomized to the liberal transfusion strategy will receive a red blood cell transfusion anytime there is a blood count of less than 10 g/dL.
Patients randomized to the restrictive transfusion strategy are permitted to receive a blood transfusion if the blood count is below 8 g/dL and the physician believes it is in the patient's best interest. A transfusion will be strongly recommended if the blood count drops to less than 7 g/dL. If the patient has symptoms of angina (e.g., chest discomfort described as pressure or heaviness) that do not go away with medication, a blood transfusion is ordered regardless of the blood count.
The transfusions strategies will be maintained until hospital discharge for a maximum of 30 days.
Patients will be followed for 30 days for clinically relevant outcomes. Vital status will be confirmed at 180 days.
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 | Active comparator | Biological: Red Blood Cell TransfusionRed blood cell transfusion - One unit of packed red cells is transfused following randomization followed by enough red blood cell units 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. |
| Restrictive Transfusion Strategy | Active comparator | Biological: Red Blood Cell TransfusionPermitted to receive a red blood cell transfusion if the blood count is below 8 g/dL and the physician believes it is in the patient's best interest. A transfusion will be strongly recommended if the blood count drops to less than 7 g/dL. If the patient has symptoms of angina (e.g., chest discomfort described as pressure or heaviness) that do not go away with medication, a blood transfusion will be ordered regardless of the blood count. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Either ST segment elevation myocardial infarction or Non ST segment elevation myocardial infarction consistent with the 3rd Universal Definition of Myocardial Infarction criteria that occurs on admission or during the index hospitalization
- Hemoglobin concentration less than 10 g/dL at the time of random allocation
- Patient physician believes that both of the transfusion strategies are consistent with good medical care for the patient
Key exclusion criteria (8 listed)
- Uncontrolled acute bleeding at the time of randomization defined as the need for uncrossed or non-type specific blood
- Decline blood transfusion
- Scheduled for cardiac surgery during the current admission
- Receiving only palliative treatment
- Known that follow-up will not be possible at 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 TransfusionTransfusion of packed red blood cell units | Biological | Liberal Transfusion Strategy, Restrictive Transfusion Strategy |
Primary outcome
Number of Participants With All-cause Mortality or Nonfatal Myocardial Reinfarction
Time frame: Within 30 days of randomization
3 secondary outcomes
All-cause Mortality
Time frame: Within 30 days of randomization
Myocardial Reinfarction
Time frame: Within 30 days of randomization
Composite of All-cause Mortality, Nonfatal Myocardial Reinfarction, Ischemia Driven Unscheduled Coronary Revascularization, or Readmission to the Hospital for Ischemic Cardiac Diagnosis
Time frame: Within 30 days of randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: 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.
- Background: PubMed 27732721Carson JL, Guyatt G, Heddle NM, Grossman BJ, Cohn CS, Fung MK, Gernsheimer T, Holcomb JB, Kaplan LJ, Katz LM, Peterson N, Ramsey G, Rao SV, Roback JD, Shander A, Tobian AA. Clinical Practice Guidelines From the AABB: Red Blood Cell Transfusion Thresholds and Storage. JAMA. 2016 Nov 15;316(19):2025-2035. doi: 10.1001/jama.2016.9185.
- Background: PubMed 36417955Carson JL, Brooks MM, Chaitman BR, Alexander JH, Goodman SG, Bertolet M, Abbott JD, Cooper HA, Rao SV, Triulzi DJ, Fergusson DA, Kostis WJ, Noveck H, Simon T, Steg PG, DeFilippis AP, Goldsweig AM, Lopes RD, White H, Alsweiler C, Morton E, Hebert PC; MINT Investigators. Rationale and design for the myocardial ischemia and transfusion (MINT) randomized clinical trial. Am Heart J. 2023 Mar;257:120-129. doi: 10.1016/j.ahj.2022.11.015. Epub 2022 Nov 20.
- Background: PubMed 37952133Carson JL, Brooks MM, Hebert PC, Goodman SG, Bertolet M, Glynn SA, Chaitman BR, Simon T, Lopes RD, Goldsweig AM, DeFilippis AP, Abbott JD, Potter BJ, Carrier FM, Rao SV, Cooper HA, Ghafghazi S, Fergusson DA, Kostis WJ, Noveck H, Kim S, Tessalee M, Ducrocq G, de Barros E Silva PGM, Triulzi DJ, Alsweiler C, Menegus MA, Neary JD, Uhl L, Strom JB, Fordyce CB, Ferrari E, Silvain J, Wood FO, Daneault B, Polonsky TS, Senaratne M, Puymirat E, Bouleti C, Lattuca B, White HD, Kelsey SF, Steg PG, Alexander JH; MINT Investigators. Restrictive or Liberal Transfusion Strategy in Myocardial Infarction and Anemia. N Engl J Med. 2023 Dec 28;389(26):2446-2456. doi: 10.1056/NEJMoa2307983. Epub 2023 Nov 11.
- Derived from this study: PubMed 42571785Kim S, Bertolet M, Chaitman BR, Alexander JH, Steg PG, Lopes RD, Simon T, Goodman SG, Strom JB, de Barros E Silva PGM, Ducrocq G, DeFilippis AP, Brooks MM, Carson J; MINT Trial investigators. Recurrent myocardial infarction identified by centralized troponin review: Insights from the MINT trial. Am Heart J. 2026 Aug 9:107553. doi: 10.1016/j.ahj.2026.107553. Online ahead of print.
- Derived from this study: PubMed 42507445Bertolet M, Carrier FM, Glynn S, Abbott JD, Defilippis AP, Simon T, Fordyce CB, Senaratne J, Potter BJ, Herbert BM, Rao SV, Caixeta A, Tessalee M, Cooper HA, Beraldo de Andrade P, Dall'Orto FTC, Silvain J, Carson JL, Brooks MM; Myocardial Ischemia and Transfusion (MINT) Trial Investigators. Restrictive vs Liberal Transfusion Strategy After Myocardial Infarction: A Post Hoc Analysis of the MINT Randomized Clinical Trial. JAMA Netw Open. 2026 Jul 1;9(7):e2624991. doi: 10.1001/jamanetworkopen.2026.24991.
- Derived from this study: PubMed 42312774DeFilippis AP, Abbott JD, Herbert BM, Bertolet MH, Chaitman BR, White HD, Goldsweig AM, Polonsky TS, Gupta R, Alsweiler C, Silvain J, de Barros E Silva PGM, Hillis GS, Daneault B, Tessalee M, Menegus MA, Rao SV, Lopes RD, Hebert PC, Alexander JH, Brooks MM, Carson JL, Goodman SG; MINT Investigators. The Effect of Restrictive vs Liberal Blood Transfusion Strategy on Subsequent Myocardial Infarction Type. JACC Adv. 2026 Jun;5(6 Pt 2):102836. doi: 10.1016/j.jacadv.2026.102836.
- Derived from this study: PubMed 42188994Cooper HA, Fordyce CB, Herbert BM, Alexander JH, Rao SV, Brooks MM, Bertolet M, Carson JL, Hebert PC; Myocardial Ischemia and Transfusion (MINT) Trial Investigators. Red Cell Transfusion in Critically Ill and Noncritically Ill Patients With Acute Myocardial Infarction and Anemia-A Subanalysis of the Myocardial Ischemia and Transfusion (MINT) Trial. Crit Care Med. 2026 Sep 1;54(9):2430-2435. doi: 10.1097/CCM.0000000000007211. Epub 2026 May 27.
- Derived from this study: PubMed 42145087Abbott JD, Benatar JR, Ballantyne CM, Jacobs AK, Goldsweig AM, Fergusson DA, Hebert BM, Bertolet M, Simon T, Steg PG, Goodman SG, White HD, Carson JL, Brooks MM; MINT Investigators. Comparative Efficacy of Transfusion Strategies in Women and Men With Myocardial Infarction and Anemia: Prespecified Secondary Findings From the MINT Trial. Circulation. 2026 Jul 21;154(3):201-211. doi: 10.1161/CIRCULATIONAHA.125.078320. Epub 2026 May 18.
- Derived from this study: PubMed 41722885Goldsweig AM, Ballantyne CM, White HD, Abbott JD, Fergusson DA, Herbert BM, Goodman SG, Carson JL, Brooks MM; MINT Investigators. Effect of age on restrictive and liberal transfusion outcomes in patients with anemia and myocardial infarction. Am Heart J. 2026 Jul;297:107381. doi: 10.1016/j.ahj.2026.107381. Epub 2026 Feb 19.
- 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 40459491Prochaska MT, Portela GT, Brooks MM, Fergusson DA, Hebert PC, Polonsky TS, Caixeta A, Cooper HA, Crozier I, Daneault B, Kim S, Bainey KR, de Barros E Silva P, Goldfarb M, Gupta R, Rao SV, Fonteles Ritt LE, Simon T, Carson JL. Transfusion Strategy Effect on Quality of Life in Patients With Myocardial Infarction and Anemia: A Secondary Analysis of the MINT Randomized Clinical Trial. JAMA Intern Med. 2025 Aug 1;185(8):947-954. doi: 10.1001/jamainternmed.2025.0654.
- Individual participant dataSharing planned: Yes. Limited access data (i.e., records without personal identifiers) will be prepared by the Data Coordinating Center (DCC) and sent to the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) within 3 years after the end of the final patient follow-up or 2 years after the main paper of the trial has been published, whichever comes first. The Trial data set will include baseline patient characteristics, follow-up status, and clinical outcome data. The data will be released to requesting institutions and investigators in accordance with BioLINCC policy.
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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 principal investigator
Rutgers Robert Wood Johnson Medical School
Maria Mori Brooks, PhD principal investigator
University of Pittsburgh
133 sites in 6 countries: 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 Anemia, run by Rutgers, The State University of New Jersey at 133 sites in 6 countries.
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 4 inclusion and 8 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 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 133 sites in United States, Canada, Brazil, France, New Zealand and 1 more country. 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 9 May 2024). 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?
Number of Participants With All-cause Mortality or Nonfatal Myocardial Reinfarction (time frame: Within 30 days of randomization). 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 NCT02981407, which also lists 21 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 9 May 2024.