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

Myocardial Ischemia Clinical Trial

— MITNECB5  

Official title:

Non-isotope Based Imaging Modalities vs 99mTcSPECT to Detect Myocardial Ischemia in Patients at High Risk for Ischemic Cardiovascular Events

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01972360
• Other study ID #: MITNEC B5
• Status: Completed
• Start date: October 2012
• Est. completion date: April 18, 2019

Study information

• Verified date: February 2020
• Source: Montreal Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 467
• Est. completion date: April 18, 2019
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 87 Years

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia

Locations

Country	Name	City	State
Canada	Montreal Heart Institute	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Montreal Heart Institute	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Specificity of "high-risk CAD" according to non-invasive imaging modality flow and FFR		baseline
Other	Positive predictive value of "high-risk CAD" according to non-invasive imaging modality flow and FFR		baseline
Other	Negative predictive value of "high-risk CAD" according to non-invasive imaging modality flow and FFR		baseline
Other	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)		baseline
Other	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)		baseline
Other	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)		baseline
Other	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)		baseline
Other	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)		baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Overall accuracy of "high-risk CAD" according to non-invasive imaging modality flow and FFR		baseline
Secondary	Sensitivity of "high-risk CAD" according to non-invasive imaging modality flow and FFR		Baseline