Plaque Registration and Event Detection In Computed Tomography

NCT00991835 | Unknown

• 1 other identifier: PREDICT2009
• Study Type: observational
• Target: 3,015
• Locations: 1 country
• Sites: 1

Brief Summary

Disruption of an atherosclerotic plaque is responsible for at least two-thirds of acute coronary syndrome. Thus, identification of plaques vulnerable to rupture has become important. The natural history of individual plaques is unknown and needs to be established. Multidetector computed tomography (MDCT) angiography is a useful noninvasive imaging modality for assessing coronary plaque characteristics. Using MDCT, the researchers prospectively investigate the relationship between the characterization of coronary plaques and cardiovascular events in a large multicenter study.

Conditions

Atherosclerosis; Cardiovascular Diseases; Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• Major cardiac events (Cardiac death and acute coronary syndrome)

  2 years after the CT-scan

• All-cause death

  2 years after the CT-scan

Secondary Outcomes (2)

• All coronary events (Cardiac death, non-fatal MI, unstable angina requiring hospitalization, late coronary revascularizations)

  2 years after CT-scan

• All cardiovascular events (Death, acute coronary syndrome, heart failure, cerebral disease, peripheral artery disease, aortic disease, and renal failure)

  2 years after the CT-scan

Other Outcomes (1)

• Coronary plaque progression and managements for serum cholesterol, blood glucose, renal function and blood pressure: Especially impacts of statin on the changes in coronary plaque characteristics

  2 years after CT

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients reffered to cardiovascular hospital

You may qualify if:

• patients with known or suspected coronary artery disease.

You may not qualify if:

• irregular heart beat,
• known allergy towards the contrast agent,
• renal dysfunction,
• uncontrolled heart failure,
• previous coronary bypass surgery, or pacemaker or ICD implantation, ST elevation MI or unstable hemodynamic condition,
• impossible breath-hold, OR
• end-stage cancer.

Sponsors & Collaborators

• Hiroshima University: lead

Study Sites (1)

Hiroshima University Graduate School of Biomedical and Health Sciences, Department of Cardiovascular Medicine

Hiroshima, Hiroshima, 734-8551, Japan

Location

Related Publications (1)

• Yamamoto H, Awai K, Kuribayashi S, Kihara Y; PREDICT Investigators. Rationale and design of the PREDICT (Plaque Registration and Evaluation Detected In Computed Tomography) registry. J Cardiovasc Comput Tomogr. 2014 Mar-Apr;8(2):90-6. doi: 10.1016/j.jcct.2013.12.004. Epub 2014 Jan 8.

  PMID: 24661823 DERIVED

MeSH Terms

Conditions

Atherosclerosis; Cardiovascular Diseases; Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Yasuki Kihara, MD,PhD

  Hiroshima University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Cardiovascular Medicine, Graduate School of Biomedical Sciences

Study Record Dates

• First Submitted: October 7, 2009
• First Posted: October 8, 2009
• Study Start: October 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2014
• Last Updated: March 20, 2013

Record last verified: 2013-03

Locations

JP (1)