Detection of Subclinical Atherosclerosis in Asymptomatic Individuals

NCT ID: NCT00862056

Last Updated: 2017-11-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 73 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2013-07-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cardiac CT

All participants will undergo a coronary artery CT angiogram

Cardiac CT

Intervention Type: PROCEDURE

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

Interventions

Cardiac CT

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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)

1. LDL > 250 mg/dL

2. HDL < 20 mg/dL

3. Triglycerides > 1000 mg/dL

4. LP(a) > 80 mg/dL

• Provide written informed consent and Authorization for Use/Disclosure of PHI

Exclusion Criteria

• 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 moderate or severe allergy to iodine-based contrast agents (mild prior reactions that could be treated as an outpatient or that could be prevented by pre-medication in the past do not constitute exclusion)
• 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Piedmont Healthcare

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Rinehart, MD

Role: PRINCIPAL_INVESTIGATOR

Piedmont Healthcare

Locations

Piedmont Hospital

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

PH08012

Identifier Type: -

Identifier Source: org_study_id