Assessment of Change in Atherosclerotic Plaque by Serial CCTA

NCT03414840 | Unknown DMC FDA Drug

• 1 other identifier: 2017-2669-001
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Coronary Arteriosclerosis

Keywords

coronary artery disease; coronary computed tomography angiography; statins; coronary atherosclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change of total atheroma volume at 24 months compared with baseline total atheroma volume

  24 months

Interventions

Atorvastatin DRUG

Patients diagnosed with coronary artery disease by CCTA be enrolled. Among enrolled patients, patients who is indicated to statin treatment according to the current ACC/AHA guideline will be treated with atorvastatin.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead
• Chong Kun Dang Pharmaceutical Corp.: collaborator

Study Sites (1)

Severance Cardiovascular Hospital, Yonsei University College of Medicine

Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Hyuk-Jae Chang, MD, PhD

  Yonsei University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyuk-Jae Chang, MD, PhD

CONTACT

+82-2-2228-8454; hjchang@yuhs.ac

Sang-Eun Lee, MD, PhD

CONTACT

tkddmss@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: January 30, 2018
• Study Start: April 1, 2018
• Primary Completion: February 28, 2020
• Study Completion: October 31, 2020
• Last Updated: June 29, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)