Clinical trial NCT00862056: Detection of Subclinical Atherosclerosis in Asymptomatic Individuals
Official title: Prospective Detection of Subclinical Atherosclerosis in Asymptomatic Individuals With High Likelihood of Coronary Artery Disease With a Novel, Low-Radiation Volumetric Computed Tomography Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: asymptomatic
coronary artery disease
Lead sponsor: Piedmont Healthcare
Sponsor class: OTHER
First posted: 2009-03-16
Enrollment: 73
Sex: ALL
Minimum age (years): 35
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Coronary Artery Disease

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.


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

Primary outcomes:
measure: 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.
timeFrame: 6 months, 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
Study officials:
affiliation: Piedmont Healthcare
name: Sarah Rinehart, MD
role: PRINCIPAL_INVESTIGATOR
References: