Myocardial Ischemia and Transfusion

Myocardial Infarction Clinical Trial

— MINT  

Official title:

Myocardial Ischemia and Transfusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02981407
• Other study ID #: Pro20160000722
• Secondary ID: 1U01HL133817-01
• Status: Completed
• Phase: Phase 3
• Start date: April 25, 2017
• Est. completion date: October 20, 2023

Study information

• Verified date: April 2024
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3506
• Est. completion date: October 20, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Coronary Artery Disease
• Infarction
• Ischemia
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Biological:
• Red Blood Cell Transfusion
Transfusion of packed red blood cell units

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Bedford Park
Australia	Concord Repatriation General Hospital	Concord
Australia	Gosford Hospital	Gosford
Australia	Royal Perth Hospital	Perth
Brazil	Hospital Felício Rocho	Belo Horizonte
Brazil	Instituto Orizonti	Belo Horizonte
Brazil	Instituto de Ensino e Pesquisa do Hospital do Coração do Brasil	Brasília
Brazil	Hospital Vera Cruz	Campinas
Brazil	Santa Casa de Marília	Cascata
Brazil	Sociedade Hospitalar Angelina Caron	Centro
Brazil	Instituto de Ensino e Pesquisa do Hospital da Bahia	Pituba	Salvador
Brazil	Hospital Maternidade e Pronto Socorro Santa Lúcia	Poços De Caldas
Brazil	Instituto de Cardiologia do RS	Porto Alegre
Brazil	Hospital Agamenon Magalhães	Recife
Brazil	Pronto Socorro Cardiológico de Pernambuco Prof. Luiz Tavares- PROCAPE	Recife
Brazil	Hospital Cárdio Pulmonar	Salvador
Brazil	Hospital Universitário Professor Edgard Santos	Salvador
Brazil	Hospital de Base de Rio Preto	São José Do Rio Preto
Brazil	Hospital de Base de Rio Preto	São José do Rio Preto	São Paulo
Brazil	Hospital São Paulo	São Paulo
Brazil	Hospital de Clínicas da UFTM	Uberaba
Brazil	Hospital das Clinicas da UFU	Uberlândia
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	Grey Nuns Community Hospital	Edmonton	Alberta
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Hôpital Charles Lemoyne	Greenfield Park	Quebec
Canada	QE II Health Sciences Center	Halifax	Nova Scotia
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	Hamilton St. Joseph's Health	Hamilton	Ontario
Canada	St. Joseph's Health Centre	Hamilton	Ontario
Canada	Hotel-Dieu de Levis	Levis	Quebec
Canada	University Hospital - LHSC	London	Ontario
Canada	Victoria Hospital - LHSC	London	Ontario
Canada	Jewish General Hospital	Montreal	Quebec
Canada	Centre Hosp. Universitaire de Montréal	Montréal	Quebec
Canada	Montreal General Hospital	Montréal	Quebec
Canada	Royal Victoria Hospital	Montréal	Quebec
Canada	Royal Columbian Hospital	New Westminster	British Columbia
Canada	Quebec Heart and Lung Institute	Québec City	Quebec
Canada	Regina General Hospital	Regina	Saskatchewan
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	Surrey Memorial Hospital	Surrey	British Columbia
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	General Hospital Trois-Rivièrs	Trois-Rivières	Quebec
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Victoria Heart Institute	Victoria	Ontario
Canada	St. Boniface General Hospital	Winnipeg	Manitoba
France	CHRU Tours -Hôpital Trousseau	Chambray-lès-Tours
France	CH Chartres - Chartres	Chartres
France	Centre Hospitalier Sud Francilien	Corbeil-Essonnes
France	CHU le Bocage - Dijon	Dijon
France	La Tronche Hôpital Michallon	La Tronche
France	Centre Hospitalier Universitaire de Lille	Lille
France	CHU Arnaud de Villeneuve - Montpellier	Montpellier
France	CHU Nancy	Nancy
France	Hôpital Pasteur	Nice
France	Hôpital Universitaire Carémeau (CHU Carémeau)	Nîmes
France	Hôpital BICHAT- APHP	Paris
France	Hôpital Européen Georges-Pompidou	Paris
France	Hôpital La Pitié Salpétrière	Paris
France	Hôpital Lariboisière	Paris
France	Hôpital Haut Lévêque	Pessac
France	CHU Poitiers - Poitiers	Poitiers
France	Hôpital Charles Nicolle- Rouen	Rouen
France	Hôpital Rangueil	Toulouse
New Zealand	Auckland City Hospital	Auckland
New Zealand	Christchurch Hospital	Christchurch
New Zealand	Gisborne Hospital	Gisborne
New Zealand	Nelson Hospital	Nelson
New Zealand	Taranaki Hospital	New Plymouth
New Zealand	Whangarei Hospital	Whangarei
United States	Albany Medical College	Albany	New York
United States	University of New Mexico	Albuquerque	New Mexico
United States	University of Michigan	Ann Arbor	Michigan
United States	Southside Hospital	Bay Shore	New York
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Boston Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	NYP Brooklyn Methodist	Brooklyn	New York
United States	Lahey Hospital	Burlington	Massachusetts
United States	University of Vermont Medical Center	Burlington	Vermont
United States	Copper University Hospital	Camden	New Jersey
United States	Aultman Hospital	Canton	Ohio
United States	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Danbury Hospital	Danbury	Connecticut
United States	Essentia Health	Duluth	Minnesota
United States	Durham Va	Durham	North Carolina
United States	Alexian Brothers Medical Center	Elk Grove Village	Illinois
United States	New York Presbyterian/Queens	Flushing	New York
United States	Greenville Health System	Greenville	South Carolina
United States	Memorial Hospital at Gulfport	Gulfport	Mississippi
United States	Hackensacjk University Medical Center	Hackensack	New Jersey
United States	Westchester Medical Center	Hawthorne	New York
United States	AMITA Health	Hinsdale	Illinois
United States	Baylor St Luke's Medical Center	Houston	Texas
United States	Saint Luke's Mid America Heart	Kansas City	Kansas
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Central Arkansas Veterans Healthcare System	Little Rock	Arkansas
United States	University of Arkansas Medical Sciences (UAMS) Hospital	Little Rock	Arkansas
United States	VAGLAHS	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	North Shore University Hospital	Manhasset	New York
United States	The Memphis VAMC	Memphis	Tennessee
United States	Medical College of Wisconsin - Froedtert Hospital	Milwaukee	Wisconsin
United States	Minneapolis Heart Institute (Foundation)	Minneapolis	Minnesota
United States	University of Minnesota Medical Center Fairview	Minneapolis	Minnesota
United States	Northern Westchester Hospital	Mount Kisco	New York
United States	Jersey Shore University Medical	Neptune	New Jersey
United States	Robert Wood Johnson University Hospital	New Brunswick	New Jersey
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	Lenox Hilll Hospital	New York	New York
United States	NYU Langone Medical Center, Bellevue Hospital	New York	New York
United States	PENN Presbyterian Medical Cente	Philadelphia	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Rhode Island Hospital	Providence	Rhode Island
United States	The Miriam Hospital	Providence	Rhode Island
United States	WakeMed Health and Hospital	Raleigh	North Carolina
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	Rochester General Hospital	Rochester	New York
United States	University of Rochester	Rochester	New York
United States	Washington University	Saint Louis	Missouri
United States	Northwell Staten Island Hopsital	Staten Island	New York
United States	Stony Brook Medicine	Stony Brook	New York
United States	University of Toledo Medical Center	Toledo	Ohio
United States	Lankenau Medical Center	Wynnewood	Pennsylvania
United States	St. Joseph Mercy Health System	Ypsilanti	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Heart, Lung, and Blood Institute (NHLBI), University of Pittsburgh

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  France,  New Zealand, 

References & Publications (4)

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. — View Citation

Carson 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. — View Citation

Carson 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Composite of All-cause Mortality,Nonfatal Myocardial Reinfarction, or Unstable Angina		Within 30 days of randomization
Other	Ischemia Driven Unscheduled Coronary Revascularization		Within 30 days of randomization
Other	Unscheduled Readmission to Hospital for Ischemic Cardiac Diagnosis		Within 30 days of randomization
Other	Heart Failure		Within 30 days of randomization
Other	Unscheduled Readmission to Hospital for Any Reason		Within 30 days of randomization
Other	Stroke		Within 30 days of randomization
Other	Pulmonary Embolism or Deep Venous Thrombosis		Within 30 days of randomization
Other	Bleed		Within 30 days of randomization
Other	Pneumonia		Within 30 days of randomization
Other	Blood Stream Infection		Within 30 days of randomization
Other	Urinary Tract Infection		Within 30 days of randomization
Other	Length of Hospital Stay Post Randomization		Within 30 days of randomization
Other	Number of Days Post Randomization in Intensive Care Unit		Within 30 days of randomization
Other	Patient Reported Quality of Life	EuroQol questionnaire	Within 30 days of randomization
Other	All-cause Mortality		Within 6 months of randomization
Primary	Number of Participants With All-cause Mortality or Nonfatal Myocardial Reinfarction		Within 30 days of randomization
Secondary	All-cause Mortality		Within 30 days of randomization
Secondary	Myocardial Reinfarction		Within 30 days of randomization
Secondary	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