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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 : Active, not recruiting
First Posted : October 30, 2013
Last Update Posted : June 14, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Montreal Heart Institute

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.

Condition or disease
Myocardial Ischemia

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
Estimated Enrollment : 450 participants
Observational Model: Other
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
Study Start Date : October 2012
Actual Primary Completion Date : April 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Diagnosis
Group 3: 99mTCSPECT plus stress echocardiography
group 1 : diagnosis
Group 1: 99mTcSPECT plus CMR
Group 2: diagnosis
Group 2: 99mTcSPECT plus CT



Primary Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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


Secondary Outcome Measures :
  1. Overall accuracy of "high-risk CAD" according to non-invasive imaging modality flow and FFR [ Time Frame: baseline ]
  2. Sensitivity of "high-risk CAD" according to non-invasive imaging modality flow and FFR [ Time Frame: Baseline ]

Other Outcome Measures:
  1. Specificity of "high-risk CAD" according to non-invasive imaging modality flow and FFR [ Time Frame: baseline ]
  2. Positive predictive value of "high-risk CAD" according to non-invasive imaging modality flow and FFR [ Time Frame: baseline ]
  3. Negative predictive value of "high-risk CAD" according to non-invasive imaging modality flow and FFR [ Time Frame: baseline ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]


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Ages Eligible for Study:   18 Years to 87 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972360


Locations
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada
Sponsors and Collaborators
Montreal Heart Institute
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Jean-Claude Tardif, M.D Montreal Heart Institute

Responsible Party: Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT01972360     History of Changes
Other Study ID Numbers: MITNEC B5
First Posted: October 30, 2013    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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