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Coronary CT Angiography as the Primary Initial Method of Evaluating Patients With Subacute Chest Pain (CT PRIME) (CTPRIME)

This study has been withdrawn prior to enrollment.
(It was decided to not proceed with the study at this time.)
Sponsor:
Information provided by:
William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00584337
First received: December 20, 2007
Last updated: April 21, 2009
Last verified: April 2009
  Purpose

This study is designed to evaluate a new approach to the diagnosis of chronic or sub-acute chest pain patients in the out-patient setting. Patients in this study are selected to be "low-risk", meaning they are not having an acute or recent heart attack (AMI), based on screening blood tests and electrocardiograms (EKGs). In addition, these patients have a low or intermediate pre-test likelihood of the coronary artery disease (CAD), which means that probability of the CAD based on the available clinical and historical information, does not make a diagnosis of the CAD a certain clinical diagnosis in the particular patient and this, in turn, requires an additional diagnostic work up.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Coronary CT Angiography as the Primary Initial Method of Evaluating Patients With Subacute Chest Pain (CT PRIME)

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • Primary outcome variable: diagnostic efficiency. [ Time Frame: 6 months, 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary outcome variables: diagnostic accuracy, prognostic accuracy. [ Time Frame: 6 months, 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: January 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)

Detailed Description:

To compare and contrast the diagnostic efficacy of coronary CT angiography (CCTA) to standard of care-myocardial perfusion imaging (MPI) as an initial diagnostic test for evaluation of patients with suspected angina pectoris and no known CAD.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  1. Non-acute (onset≥72 hours) chest pain suggestive of possible underlying CAD in out-patient.
  2. Low or low-to-intermediate clinical likelihood of the CAD.
  3. Very low or low risk Goldman-Reilly risk group.
  4. Ability to provide informed consent.
  5. Age equal to or greater than 18 years.

Exclusion Criteria:

  1. Intermediate or higher risk of ACS by Goldman-Reilly criteria:

    1. Electrographic evidence of acute ST elevation myocardial infarction (STEMI) with ST segment elevation equal to or greater than 1mm in two or more contiguous leads).
    2. Electrocardiographic evidence of acute non-ST infarction (NSTEMI) or acute myocardial ischemia, including flat to down sloping ST segment depression equal to or greater than 1mm and/or T wave inversion equal to or greater than 2mm in 2 or more leads.
    3. Positive cardiac biomarkers (troponin and/or creatinine phosphokinase MB fraction) compatible with acute myocardial infarction on initial laboratory testing, based on the local laboratory upper range of normal.
    4. Clinical instability including cardiogenic shock, hypotension (systolic blood pressure < 90 mmHg), refractory hypertension (systolic blood pressure > 180 mmHg on therapy), sustained ventricular or atrial arrhythmia requiring intravenous medications.
  2. Presence of known pre-existing coronary artery disease (known prior myocardial infarction, EKG evidence compatible with prior infarction, prior angiographic evidence of significant coronary artery disease, history of prior coronary revascularization).
  3. Presence of signs or symptoms compatible with obvious non-cardiac chest pain, including musculoskeletal, gastrointestinal or neuropathic causes.
  4. Renal insufficiency (creatinine >1.5) or history of chronic or transient renal failure.
  5. Atrial fibrillation or other markedly irregular rhythm.
  6. Pregnancy or unknown pregnancy status.
  7. Known allergy to iodinated contrast.
  8. Inability to tolerate beta-blocking drugs, including patients with reactive airways disease requiring maintenance inhaled bronchodilators or steroids, complete heart block or second-degree atrioventricular block.
  9. Iodinated 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: NCT00584337

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
Principal Investigator: Aiden Abidov, MD, PhD William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: Aiden Abidov MD, PhD, Division of Cardiology, William Beaumont Hospital
ClinicalTrials.gov Identifier: NCT00584337     History of Changes
Other Study ID Numbers: 2007-091
Study First Received: December 20, 2007
Last Updated: April 21, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
tomography
coronary artery disease
Stress Test
Coronary CT Angiography
Diagnostic Accuracy
Non invasive testing

Additional relevant MeSH terms:
Chest Pain
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Pain
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014