Ignite Creation Date:
2024-05-06 @ 2:08 AM
Last Modification Date:
2024-10-26 @ 11:14 AM
Study NCT ID:
NCT01972360
Status:
COMPLETED
Last Update Posted:
2020-02-21
First Post:
2013-07-18
Brief Title:
Non-isotope Based Imaging Modalities vs Technetium-99m Single-Photon Emission Computed Tomography99mTcSPECT
Sponsor:
Montreal Heart Institute
Organization:
Montreal Heart Institute
Study Overview
Official Title:
Non-isotope Based Imaging Modalities vs 99mTcSPECT to Detect Myocardial Ischemia in Patients at High Risk for Ischemic Cardiovascular Events
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MITNECB5
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 399mTcSPECT 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 ie invasive angiography would not be clinically indicated and FFR would be considered to be above 08 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None