Detection of Subclinical Atherosclerosis in Asymptomatic Individuals (Decide CTA)

November 16, 2017 updated by: Piedmont Healthcare

Prospective Detection of Subclinical Atherosclerosis in Asymptomatic Individuals With High Likelihood of Coronary Artery Disease With a Novel, Low-Radiation Volumetric Computed Tomography Approach

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

73

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Coronary Artery Disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Piedmont Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2009

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

March 12, 2009

First Submitted That Met QC Criteria

March 13, 2009

First Posted (ESTIMATE)

March 16, 2009

Study Record Updates

Last Update Posted (ACTUAL)

November 20, 2017

Last Update Submitted That Met QC Criteria

November 16, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PH08012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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