Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Detection of Subclinical Atherosclerosis in Asymptomatic Individuals

Lead Sponsor:

Piedmont Healthcare

Conditions:

Coronary Artery Disease

Eligibility:

All Genders

35-90 years

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2009

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

July 1 2013

Estimated Enrollment :

73 Patients enrolled

Trial Details

Trial ID

NCT00862056

Start Date

January 1 2009

End Date

July 1 2013

Last Update

November 20 2017

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Piedmont Hospital

Atlanta, Georgia, United States, 30309