CCS-AMI Staging Diagnosis by High-sensitivity Cardiac Troponin-I
NCT ID: NCT07163988
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
312 participants
OBSERVATIONAL
2023-01-10
2025-09-30
Brief Summary
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The study retrospectively analyzes biomarker data from patients diagnosed with AMI across multiple institutions, focusing on whether hs-cTnI levels-measured at specific time points-can reliably identify and stratify patients into CCS-defined AMI clinical stages (Stage 1 to Stage 4). It aims to correlate hs-cTnI kinetics and peak levels with clinical stage, presentation patterns, and outcomes.
This trial seeks to offer a biomarker-based alternative to imaging-heavy staging, potentially streamlining early diagnosis and therapeutic triage for AMI patients in varied clinical settings.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Index STEMI with Primary PCI with Stenting
The study population consists of individuals aged 18 to 80 who have been diagnosed with acute ST-elevation myocardial infarction (STEMI) and are scheduled for emergency percutaneous coronary intervention (PCI).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Index STEMI
* Coronary angiogram with PCI to occur irrespective of the onset of the symptoms.
* Ability to provide informed consent for themselves
Exclusion Criteria
* Cardiogenic shock,
* Patients who present with current cardiac arrest
* Any contraindication to cardiac CMR (claustrophobia, pacemaker or cardiac defibrillator, known allergy to gadolinium),
* Presence of permanent atrial fibrillation,
* Unconscious patient,
* Severe renal insufficiency (creatinine clearance ≤ 30 ml/min/m2 or renal replacement therapy),
* Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative pregnancy test.
18 Years
79 Years
ALL
No
Sponsors
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Indiana University School of Medicine
OTHER
Synergy Cardiovascular Research Center
UNKNOWN
Indiana University
OTHER
Responsible Party
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Keyur Vora
Director, Clinical Imaging Research Trials, Medical Imaging Research Institute
Locations
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Medical Imaging Research Institute
Indianapolis, Indiana, United States
Synergy Cardiovascular Research Center
Rajkot, Gujarat, India
Countries
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References
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Vora KP, Kalra A, Shah CD, Bhatt K, Kumar A, Pandya T, Poptani V, Chan SF, Singh D, Jambunathan N, Subramanian R, Youssef K, Kanakasabai S, Finney R, Desai A, Kreutz RP, Kovacs RJ, Raman SV, Bhatt DL, Dharmakumar R. In-Hospital Mortality in Hemorrhagic Myocardial Infarction. NEJM Evid. 2025 Sep;4(9):EVIDoa2400294. doi: 10.1056/EVIDoa2400294. Epub 2025 Aug 26.
Vora KP, Kumar A, Krishnam MS, Prato FS, Raman SV, Dharmakumar R. Microvascular Obstruction and Intramyocardial Hemorrhage in Reperfused Myocardial Infarctions: Pathophysiology and Clinical Insights From Imaging. JACC Cardiovasc Imaging. 2024 Jul;17(7):795-810. doi: 10.1016/j.jcmg.2024.02.003. Epub 2024 Apr 10.
Kumar A, Connelly K, Vora K, Bainey KR, Howarth A, Leipsic J, Betteridge-LeBlanc S, Prato FS, Leong-Poi H, Main A, Atoui R, Saw J, Larose E, Graham MM, Ruel M, Dharmakumar R. The Canadian Cardiovascular Society Classification of Acute Atherothrombotic Myocardial Infarction Based on Stages of Tissue Injury Severity: An Expert Consensus Statement. Can J Cardiol. 2024 Jan;40(1):1-14. doi: 10.1016/j.cjca.2023.09.020. Epub 2023 Oct 28.
Other Identifiers
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27356b
Identifier Type: -
Identifier Source: org_study_id
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