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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 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: June 27, 2014
Last verified: June 2014
  Purpose

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.


Condition
Myocardial Ischemia

Study Type: Observational
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

Further study details as provided by Montreal Heart Institute:

Primary Outcome Measures:
  • The results (normal (-) or abnormal (+) of the 3 non-isotope based modalities [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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.


Estimated Enrollment: 450
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)
Groups/Cohorts
diagnosis
Group 3: 99mTCSPECT plus stress echocardiography
group 1 : diagnosis
Group 1: 99mTcSPECT plus CMR
Group 2: diagnosis
Group 2: 99mTcSPECT plus CT

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years to 87 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  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: NCT01972360

Contacts
Contact: Lise Robitaille 514 376-3330 ext 3612 lise.robitaille@icm-mhi.org

Locations
Canada, Quebec
Montreal Heart Institute Recruiting
Montreal, Quebec, Canada
Contact: Lise Robitaille    514 376-3330 ext 3612    lise.robitaille@icm-mhi.org   
Principal Investigator: Jean-Claude Tardif, M.D         
Sponsors and Collaborators
Montreal Heart Institute
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Jean-Claude Tardif, M.D Montreal Heart Institute
  More Information

No publications provided

Responsible Party: Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT01972360     History of Changes
Other Study ID Numbers: MITNEC B5
Study First Received: July 18, 2013
Last Updated: June 27, 2014
Health Authority: Canada: Health Canada

Keywords provided by Montreal Heart Institute:
SPECT
CMR
High risk for ischemic cardiovascular events

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

ClinicalTrials.gov processed this record on September 18, 2014