Non-isotope Based Imaging Modalities vs Technetium-99m Single-Photon Emission Computed Tomography(99mTcSPECT) (MITNECB5)
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Non-isotope Based Imaging Modalities vs 99mTcSPECT to Detect Myocardial Ischemia in Patients at High Risk for Ischemic Cardiovascular Events|
- The results (normal (-) or abnormal (+) of the 3 non-isotope based modalities [ Time Frame: one year ] [ Designated as safety issue: No ]
- 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 ]
- 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.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Group 3: 99mTCSPECT plus stress echocardiography
group 1 : diagnosis
Group 1: 99mTcSPECT plus CMR
Group 2: diagnosis
Group 2: 99mTcSPECT plus CT
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01972360
|Contact: Lise Robitaille||514 376-3330 ext firstname.lastname@example.org|
|Montreal Heart Institute||Recruiting|
|Montreal, Quebec, Canada|
|Contact: Lise Robitaille 514 376-3330 ext 3612 email@example.com|
|Principal Investigator: Jean-Claude Tardif, M.D|
|Principal Investigator:||Jean-Claude Tardif, M.D||Montreal Heart Institute|