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

NCT01972360 | Completed

• 1 other identifier: MITNEC B5
• Study Type: observational
• Target: 467
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Ischemia

Keywords

SPECT; CMR; High risk for ischemic cardiovascular events

Outcome Measures

Primary Outcomes (5)

• Overall accuracy of "significant coronary artery disease (CAD)" according to non-invasive imaging modality

  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)

  baseline

• Sensitivity of "significant CAD" according to non-invasive imaging modality

  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

  baseline

• Specificity of "significant CAD" according to non-invasive imaging modality

  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

  baseline

• Positive predictive value of "significant CAD" according to non-invasive imaging modality

  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

  baseline

• Negative predictive value of "significant CAD" according to non-invasive imaging modality

  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

  Baseline

Secondary Outcomes (2)

• Overall accuracy of "high-risk CAD" according to non-invasive imaging modality flow and FFR

  baseline

• Sensitivity of "high-risk CAD" according to non-invasive imaging modality flow and FFR

  Baseline

Other Outcomes (8)

• Specificity of "high-risk CAD" according to non-invasive imaging modality flow and FFR

  baseline

• Positive predictive value of "high-risk CAD" according to non-invasive imaging modality flow and FFR

  baseline

• Negative predictive value of "high-risk CAD" according to non-invasive imaging modality flow and FFR

  baseline

Study Arms (3)

Diagnosis

Group 3: 99mTCSPECT plus stress echocardiography

group 1 : diagnosis

Group 1: 99mTcSPECT plus CMR

Group 2: diagnosis

Group 2: 99mTcSPECT plus CT

Eligibility Criteria

• Age: 18 Years - 87 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Montreal Heart Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Jean-Claude Tardif, M.D

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: October 30, 2013
• Study Start: October 1, 2012
• Primary Completion: May 1, 2018
• Study Completion: April 18, 2019
• Last Updated: February 21, 2020

Record last verified: 2020-02

Locations

CA (1)