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

NCT00584337 | Withdrawn DMC

• 1 other identifier: 2007-091
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

tomography; coronary artery disease; Stress Test; Coronary CT Angiography; Diagnostic Accuracy; Non invasive testing

Outcome Measures

Primary Outcomes (1)

• Primary outcome variable: diagnostic efficiency.

  6 months, 1 year

Secondary Outcomes (1)

• Secondary outcome variables: diagnostic accuracy, prognostic accuracy.

  6 months, 1 year

Study Arms (2)

1

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Intermediate or higher risk of ACS by Goldman-Reilly criteria:
• 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).
• 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.
• 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.
• 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.
• 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).
• Presence of signs or symptoms compatible with obvious non-cardiac chest pain, including musculoskeletal, gastrointestinal or neuropathic causes.
• Renal insufficiency (creatinine \>1.5) or history of chronic or transient renal failure.
• Atrial fibrillation or other markedly irregular rhythm.
• Pregnancy or unknown pregnancy status.
• Known allergy to iodinated contrast.
• 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.
• Iodinated 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 Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Aiden Abidov, MD, PhD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: January 2, 2008
• Study Start: January 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2010
• Last Updated: June 15, 2016

Record last verified: 2016-06

Locations

US (1)