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Detection of Subclinical Atherosclerosis in Asymptomatic Individuals (Decide CTA)

This study is currently recruiting participants.
Verified December 2012 by Piedmont Healthcare
Sponsor:
Information provided by (Responsible Party):
Piedmont Healthcare
ClinicalTrials.gov Identifier:
NCT00862056
First received: March 12, 2009
Last updated: December 17, 2012
Last verified: December 2012
History of Changes
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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

Resource links provided by NLM:

U.S. FDA Resources

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

Whole blood for DNA and RNA analysis for genetics and genomics


Estimated Enrollment: 300
Study Start Date: January 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (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: Sarah Rinehart, MD 404-605-4905 sarah.rinehart@piedmont.org
Contact: Nancy Flockhart 404-605-2875 nancy.flockhart@piedmont.org

Locations
United States, Georgia
Piedmont Hospital Recruiting
Atlanta, Georgia, United States, 30309
Contact: Nancy Flockhart     404-605-2875     nancy.flockhart@piedmont.org    
Contact: Sarah Rinehart, MD     404-605-4905     sarah.rinehart@piedmont.org    
Principal Investigator: Sarah Rinehart, MD            
Sponsors and Collaborators
Piedmont Healthcare
Investigators
Principal Investigator: Sarah Rinehart, MD Piedmont Healthcare
  More Information

No publications provided

Responsible Party: Piedmont Healthcare
ClinicalTrials.gov Identifier: NCT00862056     History of Changes
Other Study ID Numbers: PH08012
Study First Received: March 12, 2009
Last Updated: December 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Piedmont Healthcare:
asymptomatic
coronary artery disease

Additional relevant MeSH terms:
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on June 13, 2013