Clinical trial NCT01972360: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Ischemia
Keywords: SPECT
CMR
High risk for ischemic cardiovascular events
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2013-10-30
Enrollment: 467
Sex: ALL
Minimum age (years): 18
Maximum age (years): 87
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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).

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)

Primary outcomes:
measure: Overall accuracy of "significant coronary artery disease (CAD)" according to non-invasive imaging modality
timeFrame: baseline
measure: Sensitivity of "significant CAD" according to non-invasive imaging modality
timeFrame: baseline
measure: Specificity of "significant CAD" according to non-invasive imaging modality
timeFrame: baseline
measure: Positive predictive value of "significant CAD" according to non-invasive imaging modality
timeFrame: baseline
measure: Negative predictive value of "significant CAD" according to non-invasive imaging modality
timeFrame: Baseline
Secondary outcomes:
measure: Overall accuracy of "high-risk CAD" according to non-invasive imaging modality flow and FFR
timeFrame: baseline
measure: Sensitivity of "high-risk CAD" according to non-invasive imaging modality flow and FFR
timeFrame: Baseline
Other outcomes:
measure: Specificity of "high-risk CAD" according to non-invasive imaging modality flow and FFR
timeFrame: baseline
measure: Positive predictive value of "high-risk CAD" according to non-invasive imaging modality flow and FFR
timeFrame: baseline
measure: Negative predictive value of "high-risk CAD" according to non-invasive imaging modality flow and FFR
timeFrame: baseline
measure: 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)
timeFrame: baseline
measure: 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)
timeFrame: baseline
measure: 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)
timeFrame: baseline
measure: 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)
timeFrame: baseline
measure: 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)
timeFrame: baseline
Locations:
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: Jean-Claude Tardif, M.D
role: PRINCIPAL_INVESTIGATOR
References: