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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02981407




Registration number
NCT02981407
Ethics application status
Date submitted
1/12/2016
Date registered
5/12/2016
Date last updated
9/05/2024

Titles & IDs
Public title
Myocardial Ischemia and Transfusion
Scientific title
Myocardial Ischemia and Transfusion
Secondary ID [1] 0 0
1U01HL133817-01
Secondary ID [2] 0 0
Pro20160000722
Universal Trial Number (UTN)
Trial acronym
MINT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial Infarction 0 0
Anemia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Red Blood Cell Transfusion

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.

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.


Treatment: Other: Red Blood Cell Transfusion
Transfusion of packed red blood cell units
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With All-cause Mortality or Nonfatal Myocardial Reinfarction
Timepoint [1] 0 0
Within 30 days of randomization
Secondary outcome [1] 0 0
All-cause Mortality
Timepoint [1] 0 0
Within 30 days of randomization
Secondary outcome [2] 0 0
Myocardial Reinfarction
Timepoint [2] 0 0
Within 30 days of randomization
Secondary outcome [3] 0 0
Composite of All-cause Mortality, Nonfatal Myocardial Reinfarction, Ischemia Driven Unscheduled Coronary Revascularization, or Readmission to the Hospital for Ischemic Cardiac Diagnosis
Timepoint [3] 0 0
Within 30 days of randomization

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/04/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/10/2023
Sample size
Target
Accrual to date
Final
3506
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
Gosford Hospital - Gosford
Recruitment hospital [4] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment postcode(s) [2] 0 0
- Concord
Recruitment postcode(s) [3] 0 0
- Gosford
Recruitment postcode(s) [4] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
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United States of America
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Louisiana
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United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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Mississippi
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United States of America
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Missouri
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United States of America
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New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Pennsylvania
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Rhode Island
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United States of America
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South Carolina
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United States of America
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Tennessee
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Texas
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Vermont
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United States of America
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Virginia
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United States of America
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Wisconsin
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Brazil
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Salvador
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Brazil
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São Paulo
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Brazil
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Belo Horizonte
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Brazil
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Brasília
Country [30] 0 0
Brazil
State/province [30] 0 0
Campinas
Country [31] 0 0
Brazil
State/province [31] 0 0
Cascata
Country [32] 0 0
Brazil
State/province [32] 0 0
Centro
Country [33] 0 0
Brazil
State/province [33] 0 0
Porto Alegre
Country [34] 0 0
Brazil
State/province [34] 0 0
Poços De Caldas
Country [35] 0 0
Brazil
State/province [35] 0 0
Recife
Country [36] 0 0
Brazil
State/province [36] 0 0
São José Do Rio Preto
Country [37] 0 0
Brazil
State/province [37] 0 0
Uberaba
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Brazil
State/province [38] 0 0
Uberlândia
Country [39] 0 0
Canada
State/province [39] 0 0
Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Nova Scotia
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Canada
State/province [43] 0 0
Ontario
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Canada
State/province [44] 0 0
Quebec
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Canada
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Saskatchewan
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France
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Chambray-lès-Tours
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France
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Chartres
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France
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Corbeil-Essonnes
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France
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Dijon
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France
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La Tronche
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France
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Lille
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France
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Montpellier
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France
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Nancy
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France
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Nice
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France
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Nîmes
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France
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Paris
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France
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Pessac
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France
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Poitiers
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France
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Rouen
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France
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Toulouse
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New Zealand
State/province [61] 0 0
Auckland
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New Zealand
State/province [62] 0 0
Christchurch
Country [63] 0 0
New Zealand
State/province [63] 0 0
Gisborne
Country [64] 0 0
New Zealand
State/province [64] 0 0
Nelson
Country [65] 0 0
New Zealand
State/province [65] 0 0
New Plymouth
Country [66] 0 0
New Zealand
State/province [66] 0 0
Whangarei

Funding & Sponsors
Primary sponsor type
Other
Name
Rutgers, The State University of New Jersey
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Pittsburgh
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
National Heart, Lung, and Blood Institute (NHLBI)
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT02981407
Trial related presentations / 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.
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, 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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Jeffrey L Carson, MD
Address 0 0
Rutgers Robert Wood Johnson Medical School
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02981407