Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419894
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-03
Brief Title:
Advanced Cardiac Magnetic Resonance Imaging for Assessment of Obstructive Coronary Artery Disease ADVOCATE-CMR
Sponsor:
Amsterdam UMC location VUmc
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
Advanced Cardiac Magnetic Resonance Imaging for Assessment of Obstructive Coronary Artery Disease ADVOCATE-CMR
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
ADVOCATE-CMR
Brief Summary:
Stress perfusion cardiovascular magnetic resonance CMR imaging is an established non-invasive imaging test for detection of obstructive coronary artery disease CAD Fully automated quantitative perfusion CMR QP CMR is a new technical advancement which offers measurement of myocardial blood flow in CMR Additionally recent innovations have introduced various contrast-agent-free methods for CAD assessment such as stress T1 mapping reactivity T1 and oxygen-sensitive CMR OS CMR These methods might eliminate the necessity for contrast administration in clinical practice simplifying reducing time invasiveness and costs in evaluating patients with suspected obstructive CAD The ADVOCATE-CMR study aims to validate QP CMR T1 and OS CMR imaging against invasive fractional flow reserve FFR for detection of obstructive CAD The study also aims to head-to-head compare the diagnostic accuracy of these CMR techniques with the conventional visual assessment of stress perfusion CMR and to correlate them to short- and long-term clinical outcomes
Detailed Description:
Study design Single-center observational prospective cross-sectional cohort study performed at the Amsterdam University Medical Centers - Location VUmc
Study population 182 symptomatic patients with suspected obstructive CAD without a previous CAD history scheduled for invasive coronary angiography ICA according to the decision of the treating clinician
Methods
1 CMR image acquisition prior to clinically scheduled ICA using the following pulse sequences cine imaging OS-CMR with breathing maneuvers adenosine-stress and rest T1 mapping adenosine-stress and rest QP-CMR late gadolinium enhancement
2 Fractional flow reserve FFR instantaneous wave-free ratio iFR ratio between proximal and distal coronary pressures over entire resting cycle period PdPa ratio coronary flow reserve CFR and index of microcircular resistance IMR in all main coronary arteries during ICA
3 Follow-up CMR according to the abovementioned protocol 3 months after ICA or 3 months after revascularization if performed separately more than 1 day following ICA
4 Clinical follow-up - 3 6 months 1 and 3 years after ICA or revascularization if performed separately more than 1 day following ICA
Study population 182 symptomatic patients with suspected obstructive CAD without a previous CAD history scheduled for invasive coronary angiography ICA according to the decision of the treating clinician
Methods
1 CMR image acquisition prior to clinically scheduled ICA using the following pulse sequences cine imaging OS-CMR with breathing maneuvers adenosine-stress and rest T1 mapping adenosine-stress and rest QP-CMR late gadolinium enhancement
2 Fractional flow reserve FFR instantaneous wave-free ratio iFR ratio between proximal and distal coronary pressures over entire resting cycle period PdPa ratio coronary flow reserve CFR and index of microcircular resistance IMR in all main coronary arteries during ICA
3 Follow-up CMR according to the abovementioned protocol 3 months after ICA or 3 months after revascularization if performed separately more than 1 day following ICA
4 Clinical follow-up - 3 6 months 1 and 3 years after ICA or revascularization if performed separately more than 1 day following ICA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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