Personalized Risk Evaluation and Diagnosis (Using Corus CAD or ASGES) in the Coronary Tree

Completed

Conditions studied: Coronary Artery Disease, Angina Pectoris, Chest Pain, Cardiovascular Diseases, Coronary Heart Disease, CAD, CVD, CHD

In brief

The PREDICT study is to develop and validate a diagnostic blood ASGES (age, sex, gene expression score) or Corus CAD for atherosclerotic coronary artery disease (CAD). The Corus CAD (Age/Sex/Gene Expression score - ASGES) will use quantitative real-time PCR (RT-PCR) to quantify the expression of multiple genes from circulating peripheral blood cells to assess the presence of clinically significant CAD in a patient.

Key facts

Study ID

NCT00500617

Run by

CardioDx

People needed

4350

Starts

2007-07-01

Expected to finish

2011-09-01

Last updated by the study team

2019-01-31

Who can join

Age: 21 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Referral for a coronary angiogram (either invasive X-ray angiography or coronary CTA)
• Any one of the following clinical syndromes:
• chest pain syndrome, stable angina, or anginal equivalent suggesting myocardial ischemia
• low-risk unstable angin, or
• asymptomatic individuals with a high probability of CAD

You may not qualify if…

• History of myocardial infarction or known CAD
• Current Myocardial Infarct (MI), acute coronary syndrome with high-risk features or unstable angina with high-risk features
• New York Heart Association (NYHA) class III or IV congestive
• Inability to give informed congestive heart failures
• Severe left ventricular systolic dysfunction (LVEF<35%)
• Severe regurgitant or stenotic cardiac valve lesion
• Active or chronic systemic infection
• Rheumatologic, autoimmune or hematologic conditions
• Any organ transplant
• Immunosuppressive therapy
• Chemotherapy in the preceding year
• Major blood or blood product transfusion in the preceding 2 months

Where it is running

• Alaska Heart Institute — Anchorage, Alaska, United States
• CV Medical Group Southern California — Beverly Hills, California, United States
• Scripps HealthCare — La Jolla, California, United States
• Washington Hospital Medical Center — Washington D.C., District of Columbia, United States
• Fuqua Heart Center of Atlanta — Atlanta, Georgia, United States
• Minneapolis Heart Institute — Minneapolis, Minnesota, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Allegheny Hospital — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Intermountain HealthCare — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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