Impact of OCT on Outcomes in AMI

• Sponsor: Beijing Luhe Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05266547
• Collaborator: (none)
• Enrollment: 1,600
• Location: 1
• Anticipated Duration (Months): 96
• Patients Per Site Per Month: 16.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myocardial Infarction	Device: OCT guided coronary intervention

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1600 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Impact of Optical Coherence Tomography on Long-term Clincal Outcomes in Patients With Acute Myocardial Infarction
• Actual Study Start Date: Jan 1, 2016
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
OCT guided group	Device: OCT guided coronary intervention; patients were divided into two groups,on OCT guided coronary group and coronary angiography guided group
angiography guided group	Device: OCT guided coronary intervention; patients were divided into two groups,on OCT guided coronary group and coronary angiography guided group

Outcome Measures

Primary Outcome Measures

1. major adverse cardiovascular event [3 year]

   including cardiovascualr death, myocardial infarction, and target lesion revascularization, target vessel revascularization

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Luhe Hospital	Beijing		China	100000

Sponsors and Collaborators

• Beijing Luhe Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jincheng Guo, chairman of CCU, Beijing Luhe Hospital
• ClinicalTrials.gov Identifier: NCT05266547
• Other Study ID Numbers: BeijngLH
• First Posted: Mar 4, 2022
• Last Update Posted: Mar 4, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jincheng Guo, chairman of CCU, Beijing Luhe Hospital: Tomography, Optical Coherence; STEMI; NSTEMI; Major adverse cardiovascular event
• Additional relevant MeSH terms: Myocardial Infarction; Infarction

Study Results

No Results Posted as of Mar 4, 2022