Impact of OCT on Outcomes in AMI

• Conditions: Acute Myocardial Infarction
• Interventions: Device: OCT guided coronary intervention

• Registration Number: NCT05266547
• Lead Sponsor: Beijing Luhe Hospital

Brief Summary

This protocol describes a retrospective, single-center study intended to test the impact of optical coherence tomography(OCT) on long term clincical outcomes in patients with acute myocardial infarction(AMI). All the patients will be followed by intracoronary OCT at medium follow-up of 3 years.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Status Verified: 2022-02
• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-02-23
• Last Update Submitted: 2022-02-23
• Study First Posted: 2022-03-04
• Last Update Posted: 2022-03-04
• Primary Completion: 2023-01-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

• Age≥18 years old
• Patients undergo cardiac catheterization and percutaneous coronary intervention(PCI) for AMI(STEMI or NSTEMI) ST-segment elevation myocardial infarction was defined according to the universal definition of myocardial infarction, symptoms onset≤ 24h.NSTEMI was defined as elevated troponin levels and the absence of ST elevation at the time of diagnosis, PCI was performed within 24hours after symtoms onset.
• Sufficient quality of the OCT recording allowing for CoreLab analysis.

Exclusion Criteria

• ostial of Left main disease
• Cardiogenic shock or severe hemodynamic instability
• Severe renal insufficiency (creatinine clearance ≤30 mL/min)
• Bacteraemia or septicaemia
• Severe coagulation disorders
• Patients with life expectancy less than 1 year
• Patients who refuse to sign the informed consent form

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OCT guided group	OCT guided coronary intervention	-
angiography guided group	OCT guided coronary intervention	-

Primary Outcome Measures

Name	Time	Method
major adverse cardiovascular event	3 year	including cardiovascualr death, myocardial infarction, and target lesion revascularization, target vessel revascularization

Trial Locations

Locations (1)

Beijing Luhe Hospital; 🇨🇳 Beijing, China