Peripheral Vascular Disease and Coronary Artery Disease

Completed

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT03971864
• Lead Sponsor: Harbin Medical University

Brief Summary

This study aims at evaluating the relationship between peripheral artery plaque characteristics evaluated by ultrasound and coronary culprit lesion characteristics evaluated by OCT in ACS patients.

Detailed Description

Patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI) and optical coherence tomography (OCT) are included in this study. Two skillful echocardiographers will evaluate peripheral artery plaque characteristics by ultrasound.Ultrasound parameters of peripheral artery will be compared among patients with different coronary culprit lesion characteristics, such as plaque rupture and plaque erosion.

Study Timeline

• Study Start: 2018-11-08
• Study First Submitted: 2019-05-30
• Study First Submitted QC: 2019-05-30
• Study First Posted: 2019-06-03
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-13
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• Diagnosed as ACS underwent coronary angiography and OCT examination
• Agreed to accept peripheral artery ultrasound examination

Exclusion Criteria

• In-stent restenosis, coronary dissection, coronary spam, thrombus
• left main artery disease
• Age>85 years old
• Cardiogenic shock or stroke admission
• Severe hepatic or renal dysfunction
• Poor quality of OCT image or massive thrombus

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in ultrasound parameters of peripheral artery plaque according to different coronary culprit lesion morphology.	Baseline	Plaque rupture is characterized by the presence of fibrous cap discontinuity with a cavity formation. plaque erosion is characterized by the presence of the attached thrombus overlying an intact and visual plaque, luminal surface irregularity at the culprit lesion in the absence of thrombus, or attenuation of the underlying plaque by thrombus without superficial lipid or calcification immediately proximal or distal to the site of thrombus.Patients with plaque erosion have less plaques, lower intima-media thickness (IMT), lower plaque score (PS) compared to patients with plaque rupture.

Trial Locations

Locations (1)

The Second Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China