Cardiac Computed Tomography In the Management of Patients With indeterminAte or inConclusive Stress Tests

NCT00541203 | Completed DMC

• 1 other identifier: 2007-120
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Coronary CT angiography (CCTA) offers great promise as a risk stratification tool in patients with suspected CAD. It has been demonstrated in a multitude of accuracy studies to have a negative predictive value averaging over 95%. This leads to the hypothesis that a negative CCTA may preclude the need for invasive testing. The purpose of this randomized controlled study is to prospectively evaluate the role of CCTA on the management of patients with inconclusive or indeterminate stress test results.CCTA is able to provide not only information on presence and extent of coronary artery calcification, but detailed coronary anatomy as well. SPECIFIC AIM # 1: To evaluate the diagnostic and prognostic performance of CCTA in patients with equivocal / intermediate stress test results as compared to conventional invasive coronary angiography. SPECIFIC AIM # 2: To evaluate the utility of CCTA in prediction of major adverse cardiac events (MACE) compared to invasive coronary angiography at 30 days, 1 year, 3 years and 5 years.

Conditions

Coronary Disease

Keywords

tomography; coronary artery disease; Stress Test; Coronary Angiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Volunteers over 18 years of age; both genders; referred from participating cardiologist's offices

You may qualify if:

• Chest pain or other symptoms suggestive of coronary artery disease.
• Pharmacologic/exercise stress test with SPECT within the past 3 months.
• "Discordant" clinical and stress results as outlined above.
• Scheduled to undergo cardiac catheterization.
• Able to provide informed consent.
• Age equal to or greater than 18 years.

You may not qualify if:

• Presence of pre-existing CAD (prior myocardial infarction, prior angiographic evidence of significant coronary artery disease, prior coronary bypass surgery) or cardiomyopathy (ejection fraction \< 45%)
• History of hypertension with severe left ventricular hypertrophy, history of cor pulmonale.
• Renal insufficiency (creatinine ≥1.6) or renal failure requiring dialysis.
• Inability or refusal to provide informed consent.
• Psychological unsuitability or extreme claustrophobia.
• Pregnancy or unknown pregnancy status.
• Age less than 18 years.
• Patients with known allergy to iodinated contrast, unable to tolerate pre-medication.
• Inability to tolerate beta-blockers, including those with COPD or asthma requiring maintenance inhaled bronchodilators or steroids, complete heart block, second-degree atrioventricular block.
• Computed tomography imaging, or contrast administration, within the past 48 hours.

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Kavitha Chinnaiyan, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

• Gilbert Raff, MD

  Corewell Health East

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiovascular Imaging Education

Study Record Dates

• First Submitted: October 9, 2007
• First Posted: October 10, 2007
• Study Start: October 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 21, 2012

Record last verified: 2012-03

Locations

US (1)