Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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 March 2016 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: March 18, 2016
Last verified: March 2016

July 18, 2013
March 18, 2016
October 2012
September 2016   (final data collection date for primary outcome measure)
  • Overall accuracy of "significant coronary artery disease (CAD)" according to non-invasive imaging modality [ Time Frame: baseline ] [ Designated as safety issue: No ]
    The overall accuracy is calculated as the probability that a subject is correctly classified (presence of significant CAD or not) by non-invasive imaging modality. The standard of truth is presence of significant CAD or not according to the invasive fractional flow reserve (FFR)
  • Sensitivity of "significant CAD" according to non-invasive imaging modality [ Time Frame: baseline ] [ Designated as safety issue: No ]
    The sensitivity is calculated as the probability that a subject with presence of significant CAD according to FFR is correctly identified as such by non-invasive imaging modality
  • Specificity of "significant CAD" according to non-invasive imaging modality [ Time Frame: baseline ] [ Designated as safety issue: No ]
    The specificity is calculated as the probability that a subject with absence of significant CAD according to FFR is correctly identified as such by non-invasive imaging modality
  • Positive predictive value of "significant CAD" according to non-invasive imaging modality [ Time Frame: baseline ] [ Designated as safety issue: No ]
    The positive predictive value is calculated as the probability that a subject with presence of significant CAD according to non-invasive imaging modality truly have significant CAD according to FFR
  • Negative predictive value of "significant CAD" according to non-invasive imaging modality [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The negative predictive value is calculated as the probability that a subject with absence of significant CAD according to non-invasive imaging modality truly does not have significant CAD according to FFR
The results (normal (-) or abnormal (+) of the 3 non-isotope based modalities [ Time Frame: one year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01972360 on ClinicalTrials.gov Archive Site
  • Overall accuracy of "high-risk CAD" according to non-invasive imaging modality flow and FFR [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Sensitivity of "high-risk CAD" according to non-invasive imaging modality flow and FFR [ Time Frame: Baseline ] [ 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 ]
  • Specificity of "high-risk CAD" according to non-invasive imaging modality flow and FFR [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Positive predictive value of "high-risk CAD" according to non-invasive imaging modality flow and FFR [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Negative predictive value of "high-risk CAD" according to non-invasive imaging modality flow and FFR [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Overall accuracy of "high-risk CAD" according to non-invasive imaging modality to predict occurrence of the composite clinical endpoint of major adverse cardiovascular events (MACE) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Sensitivity of "high-risk CAD" according to non-invasive imaging modality to predict occurrence of the composite clinical endpoint of major adverse cardiovascular events (MACE) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Specificity of "high-risk CAD" according to non-invasive imaging modality to predict occurrence of the composite clinical endpoint of major adverse cardiovascular events (MACE) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Positive predictive value of "high-risk CAD" according to non-invasive imaging modality to predict occurrence of the composite clinical endpoint of major adverse cardiovascular events (MACE) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Negative predictive value of "high-risk CAD" according to non-invasive imaging modality to predict occurrence of the composite clinical endpoint of major adverse cardiovascular events (MACE) [ Time Frame: baseline ] [ 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.
 
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
April 2017
September 2016   (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
  • Coronary Artery Bypass Graft(s) surgery (CABG)
Both
18 Years to 87 Years   (Adult, Senior)
No
Contact: Chantal Lacoste 514 376-3330 ext 3604 chantal.lacoste@icm-mhi.org
Canada
 
NCT01972360
MITNEC B5
No
Undecided
Not Provided
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
March 2016

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