- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiesteder
-
-
Jiangsu
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Xuzhou, Jiangsu, Kina, 221000
- The Affiliated Hospital of Xuzhou Medical University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
AMI
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Major Adverse Cardiovascular Events (MACE)
Tidsramme: through study completion, an average of 5 years
|
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.
|
through study completion, an average of 5 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Cardiac Magnetic Resonance (CMR) Imaging Parameters
Tidsramme: Baseline
|
Presence of microvascular obstruction assessed by late gadolinium enhancement cardiovascular magnetic resonance imaging.
|
Baseline
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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