Non-isotope Based Imaging Modalities vs Technetium-99m Single-Photon Emission Computed Tomography(99mTcSPECT) (MITNECB5)

This study is currently recruiting participants.
Verified October 2013 by Montreal Heart Institute
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Montreal Heart Institute
ClinicalTrials.gov Identifier:
NCT01972360
First received: July 18, 2013
Last updated: October 24, 2013
Last verified: October 2013

July 18, 2013
October 24, 2013
October 2012
December 2014   (final data collection date for primary outcome measure)
The results (normal (-) or abnormal (+) of the 3 non-isotope based modalities [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01972360 on ClinicalTrials.gov Archive Site
Degree of coronary artery stenosis as quantified from the invasive coronary angiography TIMI flow and FFR [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
The study aims to demonstrate the non-inferiority of each non-radioisotope-based imaging modalities (CMR, CT and stress echocardiography) versus 99mTcSPECT [ Time Frame: one year ] [ Designated as safety issue: No ]
During the 6 month follow-up, major adverse cardiovascular events will be collected and adjudicated by a clinical endpoint committee. Events will be evaluated considered to have been caused by myocardial ischemia leading to modification of medication. Health-related costs, quality of life and exposure to radiation will be assessed. Using these data a cost-effectiveness analysis will be performed comparing the 3 non-isotope-based imaging to 99mTc SPECT for the detection of significant coronary artery disease.
Same as current
 
Non-isotope Based Imaging Modalities vs Technetium-99m Single-Photon Emission Computed Tomography(99mTcSPECT)
Non-isotope Based Imaging Modalities vs 99mTcSPECT to Detect Myocardial Ischemia in Patients at High Risk for Ischemic Cardiovascular Events

SPECT is currently the dominant clinical test for diagnostic and prognostic purposes as well as therapeutic decision-making. Given the shortage of nuclear reactor-produced Tc, advancing the use of non-isotope based imaging modalities has the potential to change the standard of care for patients with CAD as each one of these technics (CMR, CT, Stress echocardiography) has its own distinct potential advantages over SPECT.

Obtain a better understanding of the clinical utility of advanced non-isotope-based imaging modalities to detect relevant CAD as potential alternatives to SPECT. 450 subjects enrolled in total. Three groups of about 150 patients per group. Each group will undergo imaging with 2 modalities; Group 1: 99mTcSPECT plus CMR, Group 2: 99mTcSPECT plus CT, Group 3:99mTcSPECT plus stress echocardiography.All 450 patients will undergo standard invasive coronary angiography following completion of non-invasive imaging, except for patients in whom both nuclear and non-nuclear imaging modalities reveal a normal result confirming the absence of significant coronary artery disease (i.e invasive angiography would not be clinically indicated and FFR would be considered to be above 0.8). Thrombolysis in Myocardial Infraction (TIMI) flow will be measured in all patients undergoing angiography, and fractional flow reserve (FFR) will be measured in all patients except those with TIMI flow =0, 1 and 2. All imaging procedures must be completed within 6 weeks. All patients will have a follow-up visit at 6 months after enrolment.During the 6 month follow-up visit major adverse cardiovascular events will be collected and adjudicated by an clinical endpoint committee (CEC).

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

450 patients accross Canada. Patients will be identified after a clinically indicated SPECT for evaluation of myocardial ischemia.The investigator will assign the patient in one of the three groups based on his medical assessment and availability of equipment at the center.

Myocardial Ischemia
Not Provided
  • diagnosis
    Group 3: 99mTCSPECT plus stress echocardiography
  • group 1 : diagnosis
    Group 1: 99mTcSPECT plus CMR
  • Group 2: diagnosis
    Group 2: 99mTcSPECT plus CT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
450
December 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • clinically indicated request for SPECT
  • ability to undergo at least one of three non-nuclear imaging tests; CMR, CT or Stress Echocardiography
  • History of recent symptoms suggestive of myocardial ischemia
  • High risk for ischemic cardiovascular events

Exclusion Criteria:

  • severely reduced systolic function (LV ejection fraction less than 35%)
  • Recent (less than 3 days) acute coronary syndrome including acute myocardial infarction
  • contraindications to dipyridamole SPECT including : i)severe reactive airway disease; ii) less than 3 days post Myocardial Infarction - Acute Coronary Syndrome (MI-ACS); iii) high-grade Atrioventricular block (AV block); iv)allergy to dipyridamole or theophylline; v) caffeine within 12 hours; vi) theophylline use within 48 hours; vii) severe claustrophobia; or viii) women who may be pregnant
  • kidney dysfunction (i.e estimated Glomerular Filtration Rate (eGFR) less than 45)
  • use of investigational drug or device within 30 days of screening visit
Both
18 Years to 87 Years
No
Contact: Lise Robitaille 514 376-3330 ext 3612 lise.robitaille@icm-mhi.org
Canada
 
NCT01972360
MITNEC B5
No
Montreal Heart Institute
Montreal Heart Institute
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Jean-Claude Tardif, M.D Montreal Heart Institute
Montreal Heart Institute
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP