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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03414840
Recruitment Status : Unknown
Verified June 2018 by Hyuk-Jae Chang, Yonsei University.
Recruitment status was:  Recruiting
First Posted : January 30, 2018
Last Update Posted : June 29, 2018
Sponsor:
Collaborator:
Chong Kun Dang Pharmaceutical Corp.
Information provided by (Responsible Party):
Hyuk-Jae Chang, Yonsei University

Study Description
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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
Coronary Artery Disease Hydroxymethylglutaryl-CoA Reductase Inhibitors Coronary Arteriosclerosis Drug: Atorvastatin

Study Design
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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Change in Atherosclerotic Plaque by Serial CCTA
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Drug: Atorvastatin
    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.

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


Secondary Outcome Measures :
  1. Change of total atheroma volume at 24 months compared with baseline total atheroma volume [ Time Frame: 24 months ]
    total atheroma volume assessed by CCTA


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent clinically indicated CCTA and confirmed to have coronary atherosclerosis will be enrolled.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03414840


Contacts
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Contact: Hyuk-Jae Chang, MD, PhD +82-2-2228-8454 hjchang@yuhs.ac
Contact: Sang-Eun Lee, MD, PhD tkddmss@yuhs.ac

Locations
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Korea, Republic of
Severance Cardiovascular Hospital, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Hyuk-Jae Chang, MD, PhD         
Sponsors and Collaborators
Yonsei University
Chong Kun Dang Pharmaceutical Corp.
Investigators
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Principal Investigator: Hyuk-Jae Chang, MD, PhD Yonsei University
More Information
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Responsible Party: Hyuk-Jae Chang, Professor, Yonsei University
ClinicalTrials.gov Identifier: NCT03414840    
Other Study ID Numbers: 2017-2669-001
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, Yonsei University:
coronary artery disease
coronary computed tomography angiography
statins
coronary atherosclerosis
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arteriosclerosis
Plaque, Atherosclerotic
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
 Pathological Conditions, Anatomical
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors