Detection of Subclinical Atherosclerosis in Asymptomatic Individuals

NCT00862056 | Completed

• 1 other identifier: PH08012
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the use of cardiac CT in identifying atherosclerosis plaque in patients who have not been diagnosed with atherosclerosis and who have no symptoms of the disease but who are at risk of developing atherosclerosis based on traditional risk factors such as diabetes or a family history of coronary artery disease.

Conditions

Coronary Artery Disease

Keywords

asymptomatic; coronary artery disease

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of the study is identifying the prevalence of coronary artery disease (CAD) in an asymptomatic population of patients without prior history of, but with high likelihood of CAD.

  6 months, 1 year

Study Arms (1)

Cardiac CT

All participants will undergo a coronary artery CT angiogram

Procedure: Cardiac CT

Interventions

Cardiac CT PROCEDURE

All participants will undergo a coronary artery CT angiogram with contrast.

Cardiac CT

Eligibility Criteria

• Age: 35 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Coronary Artery Disease

You may qualify if:

• Males between ages 35-90 or females between ages 40-90
• No known coronary artery disease
• no prior coronary disease by cardiac catheterization (no more than 40% in any major epicardial vessel)
• no prior myocardial infarction
• no prior ST-elevation myocardial infarction (1 mm ST-elevation in 2 contiguous leads)
• no prior non-ST-elevation myocardial infarction (CK-MB \> 2x ULN or elevated troponin that is indicative of myocardial necrosis based on local institutional cutpoints)
• no prior coronary revascularization procedure
• Aymptomatic
• no chest pain, shortness of breath, angina or angina-equivalent that is assumed to be related to myocardial ischemia
• Presence of a high-risk feature (at least one of the following four will quality)
• High FRS ≥20% (http://hp2010.nhlbihin.net/atpiii/calculator.asp)
• Diabetes Mellitus
• Premature CAD in a first-degree relative
• High Risk Lipid Profile (must meet one of the following laboratory criteria)
• LDL \> 250 mg/dL

You may not qualify if:

• Known genetic form of hypercholesterolemia based on clinical criteria (e.g. familial hypercholesterolemia, etc.)
• Creatinine 1.5 mg/dL or greater
• Irregular rhythm precluding cardiac CT examination
• Uncontrolled hypertension (SBP\>210 mmHg or DBP\>140 mmHg on treatment)
• Known Pregnancy
• Unwilling or unable to consent
• Presence of any co-morbidity that makes life expectancy less than 24 months
• Unwilling or unable to complete follow-up
• Unwilling or unable to provide written informed consent and Authorization for Use/Disclosure of PHI

Sponsors & Collaborators

• Piedmont Healthcare: lead

Study Sites (1)

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood for DNA and RNA analysis for genetics and genomics

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Sarah Rinehart, MD

  Piedmont Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2009
• First Posted: March 16, 2009
• Study Start: January 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: November 20, 2017

Record last verified: 2017-11

Locations

US (1)