Assessment of Change in Atherosclerotic Plaque by Serial CCTA

• Conditions: Coronary Artery Disease; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Coronary Arteriosclerosis

• Registration Number: NCT03414840
• Lead Sponsor: Yonsei University

Brief Summary

Assessment of Change in AtheROSclerotic Plaque by Serial CCTA (ACROSS) is designed as a prospective observational study which aim is to demonstrate the effect of statins on coronary atherosclerosis, assessed by quantitative analysis of CCTA.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-23
• Study First Submitted QC: 2018-01-23
• Study First Posted: 2018-01-30
• Study Start: 2018-04-01
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-27
• Last Update Posted: 2018-06-29
• Primary Completion: 2020-02-28
• Study Completion: 2020-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Patients who underwent clinically indicated CCTA (index CCTA)
• Mild to moderate stenosis (25-69%) on CCTA
• ≥1 clinical risk factors (Smoking, HTN, HDL<40, Premature FHx, M ≥45, F ≥55) for CAD

Exclusion Criteria

• Acute coronary syndrome (unstable angina or MI)
• Positive (not equivocal) stress test
• Contraindications to statin

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in percent change of total atheroma volume assessed by CCTA between statin-taking and statin-naïve group	24 months	Patients indicated with statin therapy according to current guideline will receive atorvastatin.

Secondary Outcome Measures

Name	Time	Method
Change of total atheroma volume at 24 months compared with baseline total atheroma volume	24 months	total atheroma volume assessed by CCTA

Trial Locations

Locations (1)

Severance Cardiovascular Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of