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Cardiac Computed Tomography In the Management of Patients With indeterminAte or inConclusive Stress Tests (CT-MPACT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kavitha Chinnaiyan, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00541203
First received: October 9, 2007
Last updated: March 20, 2012
Last verified: March 2012
  Purpose

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.


Condition
Coronary Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiac Computed Tomography In the Management of Patients With indeterminAte or inConclusive Stress Tests

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Enrollment: 45
Study Start Date: October 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Detailed Description:

Outpatients scheduled to undergo cardiac catheterization and coronary angiography for the specific indication of inconclusive or indeterminate stress tests will be considered for this study. Patients will be initially screened by their cardiologist for the presence of inclusion/exclusion criteria, as well as pre-test and post-test likelihood of CAD.16, 17 All patients must have undergone a stress (exercise or pharmacologic) test within the past 3 months.

After consent, patients will be randomized 1:1 to undergo CCTA or cardiac catheterization. The decision whether or not to proceed with subsequent invasive cardiac catheterization (CCTA arm) or revascularization (catheterization arm) will be made by the patient's primary and interventional cardiologists respectively.

Inclusion:

  1. Chest pain or other symptoms suggestive of coronary artery disease.
  2. Pharmacologic/exercise stress test with SPECT (nuclear myocardial-heart perfusion imaging) within the past 3 months.
  3. "Discordant or conflicting findings" clinical and stress results as outlined above.
  4. Scheduled to undergo cardiac catheterization.
  5. Able to provide informed consent.
  6. Age equal to or greater than 18 years.

Exclusion:

  1. Presence of pre-existing heart disease (prior heart attack, prior angiographic evidence of significant heart disease, prior heart surgery) or cardiomyopathy (ejection fraction less than or equal to 45%)
  2. History of high blood pressure with severe left ventricular hypertrophy (thicken heart muscle), history of cor pulmonale (right heart chamber failure due to elevated blood pressures in the arteries delivering blood to the lungs).
  3. Kidney insufficiency (creatinine greater than or equal to 1.6) or kidney failure requiring dialysis.
  4. Inability or refusal to provide informed consent.
  5. Psychological unsuitability or extreme claustrophobia (fear of closed in spaces).
  6. Pregnancy or unknown pregnancy status.
  7. Age less than 18 years.
  8. Patients with known allergy to iodinated contrast, unable to tolerate pre-medication.
  9. Inability to tolerate beta-blockers (medication to slow the heart rate), including those with COPD or asthma requiring maintenance inhaled bronchodilators or steroids, complete heart block, second-degree atrioventricular block.
  10. Computed tomography imaging, or contrast administration, within the past 48 hours.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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%)
  2. History of hypertension with severe left ventricular hypertrophy, history of cor pulmonale.
  3. Renal insufficiency (creatinine ≥1.6) or renal failure requiring dialysis.
  4. Inability or refusal to provide informed consent.
  5. Psychological unsuitability or extreme claustrophobia.
  6. Pregnancy or unknown pregnancy status.
  7. Age less than 18 years.
  8. Patients with known allergy to iodinated contrast, unable to tolerate pre-medication.
  9. Inability to tolerate beta-blockers, including those with COPD or asthma requiring maintenance inhaled bronchodilators or steroids, complete heart block, second-degree atrioventricular block.
  10. Computed tomography imaging, or contrast administration, within the past 48 hours.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00541203

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
Principal Investigator: Kavitha Chinnaiyan, MD William Beaumont Hospitals
Study Director: Gilbert Raff, MD William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: Kavitha Chinnaiyan, Director, Cardiovascular Imaging Education, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00541203     History of Changes
Other Study ID Numbers: 2007-120
Study First Received: October 9, 2007
Last Updated: March 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
tomography
coronary artery disease
Stress Test
Coronary Angiography

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014