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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00584337
Recruitment Status : Withdrawn (It was decided to not proceed with the study at this time.)
First Posted : January 2, 2008
Last Update Posted : June 15, 2016
Information provided by:
William Beaumont Hospitals

Brief Summary:
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 or disease
Coronary Artery Disease

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.

Study Type : Observational
Actual Enrollment : 0 participants
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)
Study Start Date : January 2008
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Primary Outcome Measures :
  1. Primary outcome variable: diagnostic efficiency. [ Time Frame: 6 months, 1 year ]

Secondary Outcome Measures :
  1. Secondary outcome variables: diagnostic accuracy, prognostic accuracy. [ Time Frame: 6 months, 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Volunteers over 18 years of age; both genders; referred from participating cardiologist's offices

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00584337

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

Responsible Party: Aiden Abidov MD, PhD, Division of Cardiology, William Beaumont Hospital Identifier: NCT00584337     History of Changes
Other Study ID Numbers: 2007-091
First Posted: January 2, 2008    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016

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

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