Detection of Subclinical Atherosclerosis in Asymptomatic Individuals

Completed

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Cardiac CT

• Registration Number: NCT00862056
• Lead Sponsor: Piedmont Healthcare

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-03-12
• Study First Submitted QC: 2009-03-13
• Study First Posted: 2009-03-16
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-16
• Last Update Posted: 2017-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardiac CT	Cardiac CT	All participants will undergo a coronary artery CT angiogram

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Piedmont Hospital; 🇺🇸 Atlanta, Georgia, United States