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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by University of Alberta
Sponsor:
Collaborators:
AHS Cancer Control Alberta
University of Alberta
Information provided by (Responsible Party):
Harald Becher, University of Alberta
ClinicalTrials.gov Identifier:
NCT01668290
First received: August 13, 2012
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Patients With Suspected CAD: What is the Best Initial Imaging Strategy? Cardiac Computed Tomographic Angiography,(CCTA) vs Stress Echocardiography (SE) vs SPECT

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • healthcare resource utilization [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • referral rates to coronary angiography following three different initial imaging tests in this patient population. [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • coronary lesions which warrant revascularization (including those where it was warranted but not technically possible). [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • radiation exposure from the initial and subsequent imaging procedures [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • total mortality [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • freedom from angina [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • non-fatal myocardial infarction [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • hospital admissions for angina [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Groups/Cohorts
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)

Detailed Description:

This is a pilot study on imaging strategies for diagnosis of coronary artery disease. The pilot trial aims to answer the question "Which non-invasive test (single photon emission computed tomography (SPECT), stress echocardiography or coronary CT angiography (CCTA)) is the best first test in suspected coronary artery disease with respect to patient outcome and downstream health costs?" Patients are randomly assigned to one of the imaging modalities. All imaging and therapeutic procedures in this trial are clinically indicated. The only change from standard patient management is the selection of the initial imaging test. Instead of leaving the selection of the initial imaging test to the referring physician (whose decision is not evidence based), patients presenting with chest pain that fall into the inclusion/exclusion criteria of the study will be randomly assigned to one of the imaging modalities. Patients will also be followed at 1, 6 and 12 months after enrolment to determine outcomes. The three imaging strategies will be compared regarding subsequent use of healthcare resources over a year. In most large cardiac centres, different imaging modalities are performed by different specialists and therefore an operating grant from one imaging specialty rarely covers the costs of other imaging specialties in comparative studies. To ensure a fair comparison between modalities, all modalities have to be equal. Previous comparative trials have been criticized for being biased towards the technique being promoted by the principal investigator. This trial is unique in that the directors of nuclear cardiology, coronary computed tomography and echocardiography are all specialists in their field and are running state-of-the-art services and were all involved in the early planning of this trial and their involvement has ensured trial design meets clinical need. The results of this trial will give insight into planning of a larger multicentre, multi-national study.

  Eligibility

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

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  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: NCT01668290

Contacts
Contact: Victoria Sarban 780-246-2595 victoria.sarban@albertahealthservices.ca

Locations
Canada, Alberta
Mazankowski Alberta Heart Institute Recruiting
Edmonton, Alberta, Canada, T6G2B7
Contact: Victoria Sarban    780-246-2595    victoria.sarban@albertahealthservices.ca   
Sponsors and Collaborators
Harald Becher
AHS Cancer Control Alberta
University of Alberta
Investigators
Principal Investigator: Harald Becher, MD,PhD,FRCP University of Alberta, Alberta Health Services
  More Information

No publications provided

Responsible Party: Harald Becher, Heart and Stroke Foundation Chair for Cardiovascular Research, University of Alberta
ClinicalTrials.gov Identifier: NCT01668290     History of Changes
Other Study ID Numbers: CMI 1D, Pro00026591
Study First Received: August 13, 2012
Last Updated: August 14, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
Coronary Artery Disease
Stress Echocardiography
Single Photon Emission Computed Tomography
Cardiac Computed Tomographic Angiography
outcomes

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

ClinicalTrials.gov processed this record on July 22, 2014