Detection of Subclinical Atherosclerosis in Asymptomatic Individuals - Full Text View

Sponsored by:	Piedmont Healthcare
Information provided by:	Piedmont Healthcare
ClinicalTrials.gov Identifier:	NCT00862056

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease	Procedure: Cardiac CT	Phase 0

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
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

Further study details as provided by Piedmont Healthcare:

Primary Outcome Measures:

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. [ Time Frame: 6 months, 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Whole blood for DNA and RNA analysis for genetics and genomics

Estimated Enrollment:	300
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Cardiac CT All participants will undergo a coronary artery CT angiogram	Procedure: Cardiac CT All participants will undergo a coronary artery CT angiogram with contrast.

Eligibility

Ages Eligible for Study:	35 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Coronary Artery Disease

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00862056

Contacts

Contact: Szilard Voros, MD	404-605-4905	szilard.voros@piedmont.org
Contact: Laura Murrieta	404-605-3074	laura.murrieta@piedmont.org

Locations

United States, Georgia
Piedmont Hospital	Recruiting
Atlanta, Georgia, United States, 30309
Contact: Szilard Voros, MD 404-605-4905 szilard.voros@piedmont.org
Contact: Laura Murrieta 404-605-3074 laura.murrieta@piedmont.org
Principal Investigator: Szilard Voros, MD

Sponsors and Collaborators

Piedmont Healthcare

Investigators

Principal Investigator:

Szilard Voros, MD

Piedmont Healthcare

More Information

No publications provided

Responsible Party:	Piedmont Healthcare ( Szilard Voros, MD )
Study ID Numbers:	PH08012
Study First Received:	March 12, 2009
Last Updated:	March 13, 2009
ClinicalTrials.gov Identifier:	NCT00862056 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Piedmont Healthcare:

asymptomatic
coronary artery disease

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Atherosclerosis
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Ischemia
Arteriosclerosis
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Coronary Disease
Atherosclerosis
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 07, 2009