Assessment of Change in Atherosclerotic Plaque by Serial CCTA (ACROSS)

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Coronary Arteriosclerosis; Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Intervention / Treatment: Drug: Atorvastatin

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Recruiting
    • Severance Cardiovascular Hospital, Yonsei University College of Medicine
    • Contact: Hyuk-Jae Chang, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent clinically indicated CCTA and confirmed to have coronary atherosclerosis will be enrolled.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of total atheroma volume at 24 months compared with baseline total atheroma volume	total atheroma volume assessed by CCTA	24 months

Collaborators and Investigators

• Sponsor: Yonsei University
• Collaborators: Chong Kun Dang Pharmaceutical Corp.
• Investigators: Principal Investigator: Hyuk-Jae Chang, MD, PhD, Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Anticipated): February 28, 2020
• Study Completion (Anticipated): October 31, 2020

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (Actual): January 30, 2018

Study Record Updates

• Last Update Posted (Actual): June 29, 2018
• Last Update Submitted That Met QC Criteria: June 27, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: coronary artery disease; statins; coronary atherosclerosis; coronary computed tomography angiography
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Arteriosclerosis; Plaque, Atherosclerotic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: 2017-2669-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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