Impact of OCT on Outcomes in AMI

Acute Myocardial Infarction Clinical Trial

Official title:

Impact of Optical Coherence Tomography on Long-term Clincal Outcomes in Patients With Acute Myocardial Infarction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05266547
• Other study ID #: BeijngLH
• Status: Recruiting
• Start date: January 1, 2016
• Est. completion date: January 1, 2024

Study information

• Verified date: February 2022
• Source: Beijing Luhe Hospital
• Contact: Jincheng Guo, M.D.
• Phone: 8610-13521968844
• Email: guojcmd[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Device:
• OCT guided coronary intervention
patients were divided into two groups,on OCT guided coronary group and coronary angiography guided group

Locations

Country	Name	City	State
China	Beijing Luhe Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Luhe Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major adverse cardiovascular event	including cardiovascualr death, myocardial infarction, and target lesion revascularization, target vessel revascularization	3 year