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NCT03971864 Clinical Trial

Peripheral Vascular Disease and Coronary Artery Disease

Acute Coronary Syndrome Clinical Trial

Official title:
The Relationship Between Peripheral Artery Plaque Characteristics Evaluated by Ultrasound and Coronary Culprit Lesion Characteristics Evaluated by OCT in ACS Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03971864
Other study ID # HMUOCT-PAU
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 8, 2018
Est. completion date December 31, 2019

Study information
Verified date September 2020
Source Harbin Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 350
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
China The Second Affiliated Hospital of Harbin Medical University Harbin Heilongjiang

Sponsors (1)
Lead Sponsor Collaborator
Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Differences in ultrasound parameters of peripheral artery plaque according to different coronary culprit lesion morphology. 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. Baseline
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