NCT03971864

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

1.1 years

First QC Date

May 30, 2019

Last Update Submit

September 13, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

ACS patients

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150081, China

Location

Related Publications (1)

  • Weng Z, Zhao C, Qin Y, Liu C, Pan W, Hu S, He L, Xu Y, Zeng M, Feng X, Gao R, Yu X, Liu M, Yi B, Zhang D, Koniaeva E, Musin T, Mohammad D, Zhu B, Sun Y, Hou J, Tian J, Mintz GS, Jia H, Yu B. Peripheral atherosclerosis in acute coronary syndrome patients with plaque rupture vs plaque erosion: A prospective coronary optical coherence tomography and peripheral ultrasound study. Am Heart J. 2023 Sep;263:159-168. doi: 10.1016/j.ahj.2023.06.006. Epub 2023 Jun 14.

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Cardiology of The Seconf Affiliated Hospital of Harbin Mdical University

Study Record Dates

First Submitted

May 30, 2019

First Posted

June 3, 2019

Study Start

November 8, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

September 16, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations