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OpenTrials
Completed

NCT Number: NCT00862056

Detection of Subclinical Atherosclerosis in Asymptomatic Individuals

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.

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Key information

Age range

35 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)
  • LDL > 250 mg/dL
  • HDL < 20 mg/dL
  • Triglycerides > 1000 mg/dL
  • 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

Treatment and study plan

Cardiac CT

Procedure

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Piedmont Healthcare

Other

Registry information

Official study 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

Acronym: Decide CTA

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Mar 16, 2009
Registry last updated
Nov 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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