- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07602439
Early CMR in Acute MI (Early AMI-CMR)
Exploring the Application and Value of Cardiac Magnetic Resonance in Acute Myocardial Infarction
The goal of this observational study is to evaluate the clinical utility of cardiac magnetic resonance (CMR) in patients with acute myocardial infarction (AMI). This is a retrospective and prospective cohort study that has already enrolled a number of patients and will continue to enroll additional patients on a rolling basis.
The main question it aims to answer is:
How does CMR, performed acute phase, contribute to risk stratification, prognostic assessment, and long-term clinical management in patients with AMI?
Participants who have had an AMI will undergo CMR within one week of symptom onset. After discharge, they will be regularly followed up at 1, 3, 6, 9, and 12 months, and then every 6 months thereafter. Clinical outcomes will be collected during each follow-up visit.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiesteder
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Jiangsu
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Xuzhou, Jiangsu, Kina, 221000
- The Affiliated Hospital of Xuzhou Medical University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patients aged 18 years or older.
- Patients diagnosed with acute myocardial infarction.
- Patients who complete cardiovascular magnetic resonance imaging during the acute phase after symptom onset.
- Patients with available clinical, CMR, and follow-up data.
Exclusion Criteria:
- History of previous myocardial infarction.
- Severe renal insufficiency, defined as estimated glomerular filtration rate <30 mL/min/1.73 m².
- Presence of malignant tumors.
- Poor CMR image quality unsuitable for analysis.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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AMI
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Cardiovascular magnetic resonance imaging will be used to assess cardiac structure, function, myocardial injury, infarct size, late gadolinium enhancement, microvascular obstruction, and other CMR-derived parameters.
This is an observational cohort study, and no diagnostic test or treatment will be assigned by the investigators.
CMR examinations have been or will be performed as part of routine clinical evaluation according to clinical indications.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Major Adverse Cardiovascular Events (MACE)
Tidsramme: through study completion, an average of 5 years
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A composite of cardiovascular death, non-fatal myocardial infarction, unplanned coronary revascularization, and hospitalization for heart failure.
Assessed from the date of index hospitalization through the end of follow-up.
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through study completion, an average of 5 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Cardiac Magnetic Resonance (CMR) Imaging Parameters
Tidsramme: Baseline
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Presence of microvascular obstruction assessed by late gadolinium enhancement cardiovascular magnetic resonance imaging.
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Baseline
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Cardiac magnetic resonance imaging
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Chinese Academy of Medical Sciences, Fuwai HospitalNational Natural Science Foundation of China; Beijing Natural Science FoundationRekrutteringMyokardieinfarkt (MI) | Iskæmisk hjertesygdom (IHD)Kina
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University Medical Center GroningenAfsluttet
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Ottawa Hospital Research InstituteOttawa Heart Institute Research CorporationAfsluttet
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Hospices Civils de LyonAfsluttet
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Hospices Civils de LyonTrukket tilbageMitral regurgitation | Mitralventilinsufficiens
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Beth Israel Deaconess Medical CenterDana-Farber Cancer Institute; American Heart AssociationAfsluttet
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The University of Hong KongAfsluttetCovid19 | Viral luftvejsinfektionHong Kong
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Ottawa Heart Institute Research CorporationCanadian Institutes of Health Research (CIHR); The Finnish Funding Agency...AfsluttetHjertefejlCanada, Finland
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Adverum Biotechnologies, Inc.Adverum Biotechnologies SAS, a wholly owned subsidiary of Adverum Biotechnologies...AfsluttetFriedreichs ataksiFrankrig
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Weill Medical College of Cornell UniversityRekrutteringFriedreichs ataksiForenede Stater