ACROSS: Assessment of Change in Atherosclerotic Plaque by Serial CCTA
Sponsor
Yonsei University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03414840
Collaborator
Chong Kun Dang Pharmaceutical Corp. (Industry)
400
1
31
12.9
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
400 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Assessment of Change in Atherosclerotic Plaque by Serial CCTA
Actual Study Start Date
:
Apr 1, 2018
Anticipated Primary Completion Date
:
Feb 28, 2020
Anticipated Study Completion Date
:
Oct 31, 2020
Outcome Measures
Primary Outcome Measures
- 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
- Change of total atheroma volume at 24 months compared with baseline total atheroma volume [24 months]
total atheroma volume assessed by CCTA
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Severance Cardiovascular Hospital, Yonsei University College of Medicine | Seoul | Korea, Republic of | 120-752 |
Sponsors and Collaborators
- Yonsei University
- Chong Kun Dang Pharmaceutical Corp.
Investigators
- Principal Investigator: Hyuk-Jae Chang, MD, PhD, Yonsei University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hyuk-Jae Chang,
Professor,
Yonsei University
ClinicalTrials.gov Identifier:
NCT03414840
Other Study ID Numbers:
- 2017-2669-001
First Posted:
Jan 30, 2018
Last Update Posted:
Jun 29, 2018
Last Verified:
Jun 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Hyuk-Jae Chang,
Professor,
Yonsei University
Additional relevant MeSH terms: