Myocardial Ischemia and Transfusion (MINT)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myocardial Infarction; Anemia
• Intervention / Treatment: Biological: Red Blood Cell Transfusion

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 Type: Interventional
• Enrollment (Actual): 3506
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Bedford Park, Australia
    • Flinders Medical Centre
  • Concord, Australia
    • Concord Repatriation General Hospital
  • Gosford, Australia
    • Gosford Hospital
  • Perth, Australia
    • Royal Perth Hospital
• Brazil
  • Belo Horizonte, Brazil
    • Hospital Felício Rocho
  • Belo Horizonte, Brazil
    • Instituto Orizonti
  • Brasília, Brazil
    • Instituto de Ensino e Pesquisa do Hospital do Coração do Brasil
  • Campinas, Brazil
    • Hospital Vera Cruz
  • Cascata, Brazil, 17515-900
    • Santa Casa de Marília
  • Centro, Brazil, 83430-000
    • Sociedade Hospitalar Angelina Caron
  • Porto Alegre, Brazil
    • Instituto de Cardiologia do RS
  • Poços De Caldas, Brazil
    • Hospital Maternidade e Pronto Socorro Santa Lúcia
  • Recife, Brazil
    • Hospital Agamenon Magalhaes
  • Recife, Brazil
    • Pronto Socorro Cardiológico de Pernambuco Prof. Luiz Tavares- PROCAPE
  • Salvador, Brazil
    • Hospital Cardio Pulmonar
  • Salvador, Brazil
    • Hospital Universitario Professor Edgard Santos
  • São José Do Rio Preto, Brazil
    • Hospital de Base de Rio Preto
  • São Paulo, Brazil, 04024-002
    • Hospital Sao Paulo
  • Uberaba, Brazil
    • Hospital de Clínicas da UFTM
  • Uberlândia, Brazil
    • Hospital das Clinicas da UFU
  • Salvador
    • Pituba, Salvador, Brazil, 41810
      • Instituto de Ensino e Pesquisa do Hospital da Bahia
  • São Paulo
    • São José do Rio Preto, São Paulo, Brazil, 15080-310
      • Hospital de Base de Rio Preto
• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Foothills Medical Centre
    • Edmonton, Alberta, Canada
      • Royal Alexandra Hospital
    • Edmonton, Alberta, Canada
      • University of Alberta Hospital
    • Edmonton, Alberta, Canada
      • Grey Nuns Community Hospital
  • British Columbia
    • New Westminster, British Columbia, Canada
      • Royal Columbian Hospital
    • Surrey, British Columbia, Canada
      • Surrey Memorial Hospital
    • Vancouver, British Columbia, Canada
      • Vancouver General Hospital
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • St. Boniface General Hospital
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • QE II Health Sciences Center
  • Ontario
    • Hamilton, Ontario, Canada
      • Hamilton Health Sciences
    • Hamilton, Ontario, Canada
      • St. Joseph's Health Centre
    • Hamilton, Ontario, Canada
      • Hamilton St. Joseph's Health
    • London, Ontario, Canada
      • University Hospital - LHSC
    • London, Ontario, Canada
      • Victoria Hospital - LHSC
    • Toronto, Ontario, Canada
      • St. Michael's Hospital
    • Toronto, Ontario, Canada
      • Sunnybrook Health Sciences Centre
    • Victoria, Ontario, Canada
      • Victoria Heart Institute
  • Quebec
    • Greenfield Park, Quebec, Canada
      • Hopital Charles LeMoyne
    • Levis, Quebec, Canada
      • Hotel-Dieu de Levis
    • Montreal, Quebec, Canada
      • Jewish General Hospital
    • Montréal, Quebec, Canada
      • Royal Victoria Hospital
    • Montréal, Quebec, Canada
      • Centre Hosp. Universitaire de Montréal
    • Montréal, Quebec, Canada
      • Montreal General Hospital
    • Québec City, Quebec, Canada
      • Quebec Heart and Lung Institute
    • Sherbrooke, Quebec, Canada
      • Centre Hospitalier Universitaire de Sherbrooke
    • Trois-Rivières, Quebec, Canada
      • General Hospital Trois-Rivièrs
  • Saskatchewan
    • Regina, Saskatchewan, Canada
      • Regina General Hospital
• France
  • Chambray-lès-Tours, France
    • CHRU Tours -Hôpital Trousseau
  • Chartres, France
    • CH Chartres - Chartres
  • Corbeil-Essonnes, France
    • Centre Hospitalier Sud Francilien
  • Dijon, France, 21079
    • CHU le Bocage - Dijon
  • La Tronche, France
    • La Tronche Hôpital Michallon
  • Lille, France, 59000
    • Centre Hospitalier Universitaire de Lille
  • Montpellier, France
    • CHU Arnaud de Villeneuve - Montpellier
  • Nancy, France
    • Chu Nancy
  • Nice, France, 06000
    • Hopital PASTEUR
  • Nîmes, France, 30029
    • Hôpital Universitaire Carémeau (CHU Carémeau)
  • Paris, France
    • Hopital Lariboisiere
  • Paris, France, 75015
    • Hopital Europeen Georges-Pompidou
  • Paris, France, 75013
    • Hôpital La Pitié Salpêtrière
  • Paris, France, 75018
    • Hôpital BICHAT- APHP
  • Pessac, France, 33604
    • Hopital Haut Leveque
  • Poitiers, France
    • CHU Poitiers - Poitiers
  • Rouen, France
    • Hôpital Charles Nicolle- Rouen
  • Toulouse, France, 31400
    • Hopital Rangueil
• New Zealand
  • Auckland, New Zealand
    • Auckland City Hospital
  • Christchurch, New Zealand
    • Christchurch Hospital
  • Gisborne, New Zealand
    • Gisborne Hospital
  • Nelson, New Zealand
    • Nelson Hospital
  • New Plymouth, New Zealand
    • Taranaki Hospital
  • Whangarei, New Zealand
    • Whangarei Hospital
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Central Arkansas Veterans Healthcare System
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas Medical Sciences (UAMS) Hospital
  • California
    • Los Angeles, California, United States, 90073
      • VAGLAHS
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Danbury Hospital
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
    • Elk Grove Village, Illinois, United States, 60007
      • Alexian Brothers Medical Center
    • Hinsdale, Illinois, United States, 60521
      • AMITA Health
  • Kansas
    • Kansas City, Kansas, United States, 64111
      • Saint Luke's Mid America Heart
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University School of Medicine
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
    • Boston, Massachusetts, United States, 01930
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 15261
      • Beth Israel Deaconess Medical Center
    • Burlington, Massachusetts, United States, 01805
      • Lahey Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Ypsilanti, Michigan, United States, 48197
      • St. Joseph Mercy Health System
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • Essentia Health
    • Minneapolis, Minnesota, United States, 55105
      • University of Minnesota Medical Center Fairview
    • Minneapolis, Minnesota, United States, 55407-1130
      • Minneapolis Heart Institute (Foundation)
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Mississippi
    • Gulfport, Mississippi, United States, 39502
      • Memorial Hospital at Gulfport
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Copper University Hospital
    • Hackensack, New Jersey, United States, 07601
      • Hackensacjk University Medical Center
    • Neptune, New Jersey, United States, 08759
      • Jersey Shore University Medical
    • New Brunswick, New Jersey, United States, 08903
      • Robert Wood Johnson University Hospital
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College
    • Bay Shore, New York, United States, 11706
      • Southside Hospital
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Brooklyn, New York, United States, 11215
      • NYP Brooklyn Methodist
    • Flushing, New York, United States, 11355
      • New York Presbyterian/Queens
    • Hawthorne, New York, United States, 10532
      • Westchester Medical Center
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • Mount Kisco, New York, United States, 10549
      • Northern Westchester Hospital
    • New York, New York, United States, 10016
      • NYU Langone Medical Center, Bellevue Hospital
    • New York, New York, United States, 10075
      • Lenox Hilll Hospital
    • Rochester, New York, United States, 14642
      • University of Rochester
    • Rochester, New York, United States, 14450
      • Rochester General Hospital
    • Staten Island, New York, United States, 10305
      • Northwell Staten Island Hopsital
    • Stony Brook, New York, United States, 11794-8167
      • Stony Brook Medicine
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7097
      • The University of North Carolina at Chapel Hill
    • Durham, North Carolina, United States, 27705
      • Durham VA
    • Raleigh, North Carolina, United States, 27610
      • WakeMed Health and Hospital
  • Ohio
    • Canton, Ohio, United States, 44710
      • Aultman Hospital
    • Toledo, Ohio, United States, 43614
      • University of Toledo Medical Center
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17602
      • Lancaster General Hospital
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Philadelphia, Pennsylvania, United States, 19104
      • PENN Presbyterian Medical Cente
    • Pittsburgh, Pennsylvania, United States, 15261
      • University of Pittsburgh Medical Center
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Greenville Health System
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • The Memphis VAMC
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor St Luke's Medical Center
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont Medical Center
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin - Froedtert Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Liberal Transfusion Strategy; 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.	Biological: Red Blood Cell Transfusion; Transfusion of packed red blood cell units
Active Comparator: Restrictive Transfusion Strategy; 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.	Biological: Red Blood Cell Transfusion; Transfusion of packed red blood cell units

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite outcome of all-cause mortality or nonfatal myocardial reinfarction	Within 30 days of randomization

Secondary Outcome Measures

Outcome Measure	Time Frame
All-cause mortality	Within 30 days of randomization
Myocardial reinfarction	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	Within 30 days of randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of all-cause mortality,nonfatal myocardial reinfarction, or unstable angina		Within 30 days of randomization
Ischemia driven unscheduled coronary revascularization		Within 30 days of randomization
Unscheduled readmission to hospital for ischemic cardiac diagnosis		Within 30 days of randomization
Congestive heart failure		Within 30 days of randomization
Unscheduled readmission to hospital for any reason		Within 30 days of randomization
Stroke		Within 30 days of randomization
Pulmonary embolism or deep venous thrombosis		Within 30 days of randomization
Bleed		Within 30 days of randomization
Pneumonia		Within 30 days of randomization
Blood stream infection		Within 30 days of randomization
Urinary tract infection		Within 30 days of randomization
Length of hospital stay post randomization		Within 30 days of randomization
Number of days post randomization in intensive care unit		Within 30 days of randomization
Patient reported quality of life	EuroQol questionnaire	Within 30 days of randomization
All-cause mortality		Within 6 months of randomization

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); University of Pittsburgh
• Investigators: Principal Investigator: Jeffrey L Carson, MD, Rutgers Robert Wood Johnson Medical School; Principal Investigator: Maria Mori Brooks, PhD, University of Pittsburgh

Publications and helpful links

General Publications

• 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.
• Carson 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2017
• Primary Completion (Actual): May 31, 2023
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: December 1, 2016
• First Submitted That Met QC Criteria: December 1, 2016
• First Posted (Estimated): December 5, 2016

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Cardiovascular Disease; Anemia; Heart Disease; Red Blood Cell Transfusion
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Infarction; Infarction; Coronary Artery Disease; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: Pro20160000722; 1U01HL133817-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No