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

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ClinicalTrials.gov Identifier: NCT01972360
Recruitment Status : Completed
First Posted : October 30, 2013
Last Update Posted : February 21, 2020
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Montreal Heart Institute

Tracking Information
First Submitted Date July 18, 2013
First Posted Date October 30, 2013
Last Update Posted Date February 21, 2020
Study Start Date October 2012
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 18, 2016)
  • Overall accuracy of "significant coronary artery disease (CAD)" according to non-invasive imaging modality [ Time Frame: baseline ]
    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 ]
    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 ]
    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 ]
    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 ]
    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
Original Primary Outcome Measures
 (submitted: October 24, 2013)
The results (normal (-) or abnormal (+) of the 3 non-isotope based modalities [ Time Frame: one year ]
Change History
Current Secondary Outcome Measures
 (submitted: March 18, 2016)
  • Overall accuracy of "high-risk CAD" according to non-invasive imaging modality flow and FFR [ Time Frame: baseline ]
  • Sensitivity of "high-risk CAD" according to non-invasive imaging modality flow and FFR [ Time Frame: Baseline ]
Original Secondary Outcome Measures
 (submitted: October 24, 2013)
Degree of coronary artery stenosis as quantified from the invasive coronary angiography TIMI flow and FFR [ Time Frame: one year ]
Current Other Pre-specified Outcome Measures
 (submitted: March 18, 2016)
  • Specificity of "high-risk CAD" according to non-invasive imaging modality flow and FFR [ Time Frame: baseline ]
  • Positive predictive value of "high-risk CAD" according to non-invasive imaging modality flow and FFR [ Time Frame: baseline ]
  • Negative predictive value of "high-risk CAD" according to non-invasive imaging modality flow and FFR [ Time Frame: baseline ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Other Pre-specified Outcome Measures
 (submitted: October 24, 2013)
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 ]
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.
 
Descriptive Information
Brief Title Non-isotope Based Imaging Modalities vs Technetium-99m Single-Photon Emission Computed Tomography(99mTcSPECT)
Official Title Non-isotope Based Imaging Modalities vs 99mTcSPECT to Detect Myocardial Ischemia in Patients at High Risk for Ischemic Cardiovascular Events
Brief Summary 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.
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. Approximately 450 subjects will be 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 enrollment. During the 6 month follow-up visit major adverse cardiovascular events will be collected and adjudicated by a clinical endpoint committee (CEC).
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Approximately 450 patients across 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 centre.
Condition Myocardial Ischemia
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 11, 2019)
467
Original Estimated Enrollment
 (submitted: October 24, 2013)
450
Actual Study Completion Date April 18, 2019
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility 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
  • Coronary Artery Bypass Graft(s) surgery (CABG)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 87 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT01972360
Other Study ID Numbers MITNEC B5
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Montreal Heart Institute
Study Sponsor Montreal Heart Institute
Collaborators Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Jean-Claude Tardif, M.D Montreal Heart Institute
PRS Account Montreal Heart Institute
Verification Date February 2020