Ignite Creation Date:
2024-05-06 @ 8:38 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02786134
Status:
COMPLETED
Last Update Posted:
2021-01-06
First Post:
2016-05-20
Brief Title:
Coronary Flow Reserve to Assess Cardiovascular Inflammation CIRT-CFR
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Coronary Flow Reserve to Assess Cardiovascular Inflammation CIRT-CFR
Status:
COMPLETED
Status Verified Date:
2020-12
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:
CIRT-CFR
Brief Summary:
Coronary flow reserve CFR calculated as the ratio of hyperemic over rest myocardial blood flow is emerging as a powerful quantitative prognostic imaging marker of clinical cardiovascular risk CFR provides a robust and reproducible clinical measure of the integrated hemodynamic effects of epicardial coronary artery disease CAD diffuse atherosclerosis and microvascular dysfunction on myocardial tissue perfusion Inflammation is a key mediator of this constellation of abnormalities affecting the entire coronary vasculature but no clinical trial to date has shown that directly reducing inflammation lowers cardiovascular event rates As such the recently launched Cardiovascular Inflammation Reduction Trial CIRT provides a unique opportunity for mechanistic investigation of the impact of anti-inflammatory therapy on changes in CFR as a reflection of coronary vascular dysfunction which may precede clinical outcomes particularly in patients at high-risk of events The investigators are ideally positioned to examine the impact of inflammation on CFR having extensive experience in both the quantitation of CFR using clinically-integrated dynamic positron emission tomography PET and the ability to assess its association with cardiovascular outcomes The central hypothesis of this ancillary proposal CIRT-CFR is that reducing systemic inflammation using low-dose methotrexate LDM will compared to placebo quantitatively improve myocardial blood flow and coronary flow reserve as measured by PET over one year in stable CAD patients with type 2 diabetes or metabolic syndrome enrolled in CIRT In so doing improvement in coronary vasoreactivity endothelial function and tissue perfusion may have beneficial effects on myocardial mechanics left ventricular deformation and function and ultimately symptoms and prognosis
Detailed Description:
Randomization and double-blind study treatment period to either placebo or LDM 11 of willing and eligible patients will occur at the end of the open label run-in phase per the parent CIRT protocol and will be stratified by time since the qualifying event 6 or 6 months from the date of MI or most recent angiogram type of event MI or multivessel CAD presence of either type 2 DM or metabolic syndrome and site which will ensure balance in the proposed study Patients willing to participate in CIRT will be asked to enroll into the sub-study and may sign the CIRT-CFR informed consent at any point between signing the parent CIRT informed consent and completing the parent CIRT randomization visit Visit 4 After giving informed consent for the ancillary CIRT-CFR patients will undergo the baseline PET scan along with echocardiography at any point between the parent CIRT post run-in visit Visit 3 and up to 4 weeks after randomization Visit 4
Imaging will be performed at the 3 imaging centers BWH OHI and UAB To minimize participant and site burden only a baseline and single follow-up imaging time point will be pursued Imaging tests PET and echo will be scheduled on the same day for patient convenience if possible and no more than one week apart Baseline study visit imaging will follow the open label run-in period of the parent trial to enhance long-term compliance and eliminate risk of radiation exposure for any individuals with immediate intolerance to the LDM study protocol The imaging tests proposed are non-invasive routinely performed and historically well tolerated by patients
Imaging will be performed at the 3 imaging centers BWH OHI and UAB To minimize participant and site burden only a baseline and single follow-up imaging time point will be pursued Imaging tests PET and echo will be scheduled on the same day for patient convenience if possible and no more than one week apart Baseline study visit imaging will follow the open label run-in period of the parent trial to enhance long-term compliance and eliminate risk of radiation exposure for any individuals with immediate intolerance to the LDM study protocol The imaging tests proposed are non-invasive routinely performed and historically well tolerated by patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None