Assessment of Patients With Suspected Coronary Artery Disease (CAD): What is the Best Initial Imaging Strategy?

NCT01668290 | Completed

• 2 other identifiers: CMI 1DPro00026591
• Study Type: observational
• Target: 173
• Locations: 1 country
• Sites: 1

Brief Summary

Patients who present with chest pain are investigated with tests designed to confirm or exclude the presence of Coronary Artery Disease (CAD), as well as determine risk of poor outcome. It is not known which imaging test would be best when used first for investigating a patient presenting with exertional chest pain. This trial is designed to compare outcomes of the use of coronary CT, stress echocardiography and nuclear perfusion (SPECT) in a pilot study. Patients with no history of coronary disease presenting with chest pain will be randomly assigned to one of the three test modalities as the initial imaging test. The three imaging strategies will be compared regarding the subsequent use of healthcare resources over a year.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease; Stress Echocardiography; Single Photon Emission Computed Tomography; Cardiac Computed Tomographic Angiography; outcomes

Outcome Measures

Primary Outcomes (1)

• healthcare resource utilization

  12 month

Secondary Outcomes (7)

• referral rates to coronary angiography following three different initial imaging tests in this patient population.

  12 month

• coronary lesions which warrant revascularization (including those where it was warranted but not technically possible).

  12 month

• radiation exposure from the initial and subsequent imaging procedures

  12 month

• total mortality

  12 month

• freedom from angina

  12 month

Study Arms (3)

Stress Echocardiography

Patients will be randomized to one of three imaging modalities. One imaging modality thay can be randomized to is Stress Echocardiography.

SPECT

Patients will be randomized to one of three imaging modalities. One imaging modality thay can be randomized to is Single Photon Emission Computed Tomography (SPECT)

CCTA

Patients will be randomized to one of three imaging modalities. One imaging modality thay can be randomized to is Cardiac Computed Tomographic Angiography (CCTA)

Eligibility Criteria

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

Study Population

Men and women without known CAD who present with symptoms suggestive of CAD and require diagnostic/prognostic workup.

You may qualify if:

• Adult Age ≥ 18 years
• Presenting with symptoms suggestive of CAD requiring diagnostic/prognostic workup
• Suitable for Contrast Stress Echocardiography, SPECT and CCTA
• Able and willing to provide consent

You may not qualify if:

• Patients with documented CAD (previous invasive angiography, previous STEMI, previous PCI or CABG)
• NSTEMI, ACS within 3 months
• Previous diagnostic imaging tests in the past 6 months
• Women who are pregnant as evidenced by positive pregnancy test
• Breast feeding females
• Significant valvular heart disease (i.e. severe aortic stenosis or regurgitation or severe mitral regurgitation)
• Hemodynamic instability (blood pressure \>210/110 ml/Hg or \<90/60 mm/Hg)
• Unavailability for follow-up
• Renal insufficiency, eGFR \< 30 ml/minute unless on dialysis
• Known allergy to x-ray or echo contrast agents
• Weight exceeding specifications of nuclear equipment (\>250 Kg)
• Unable to give informed consent

Sponsors & Collaborators

• Harald Becher: lead
• Alberta Health services: collaborator
• University of Alberta: collaborator

Study Sites (1)

Mazankowski Alberta Heart Institute

Edmonton, Alberta, T6G2B7, Canada

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

• Harald Becher, MD,PhD,FRCP

  University of Alberta, Alberta Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Heart and Stroke Foundation Chair for Cardiovascular Research

Study Record Dates

• First Submitted: August 13, 2012
• First Posted: August 20, 2012
• Study Start: July 1, 2012
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: March 16, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)