Ignite Creation Date:
2024-05-06 @ 2:47 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04420325
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2020-06-03
Brief Title:
COronary and MICrocirculatory Measurements in Patients With Aortic Valve Stenosis
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
COronary and MICrocirculatory Measurements in Patients With Aortic Valve the COMIC AS Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
COMIC-AS
Brief Summary:
Although concomitant coronary artery disease CAD is frequent in patients with severe aortic stenosis AS hemodynamic assessment of CAD severity in patients undergoing valve replacement for severe AS is challenging Myocardial hypertrophic remodeling interferes with coronary blood flow and may influence the values of fractional flow reserve FFR and nonhyperemic pressure ratios NHPRs The aim of the current study is to investigate the effect of the AS and its treatment on current indices used for evaluation of CAD The investigators will compare intracoronary hemodynamics before immediately after and 6 mo after aortic valve replacement AVR when it is expected that microvascular function has improved Furthermore the investigators will compare FFR and resting full-cycle ratio RFR with myocardial perfusion single-photon emission-computed tomography SPECT as indicators of myocardial ischemia in patients with AS and CAD One-hundred consecutive patients with AS and intermediate CAD will be prospectively included Patients will undergo pre-AVR SPECT and intracoronary hemodynamic assessment at baseline immediately after valve replacement if transcatheter AVR TAVR is chosen and 6 mo after AVR The primary end point is the change in FFR 6 mo after AVR Secondary end points include the acute change of FFR after TAVR the diagnostic accuracy of FFR versus RFR compared with SPECT for the assessment of ischemia changes in microvascular function as assessed by the index of microcirculatory resistance IMR and the effect of these changes on FFR The present study will evaluate intracoronary hemodynamic parameters before immediately after and 6 mo after AVR in patients with AS and intermediate coronary stenosis The understanding of the impact of AVR on the assessment of FFR NHPR and microvascular function may help guide the need for revascularization in patients with AS and CAD planned for AVR
Detailed Description:
httpsjournalsphysiologyorgdoifull101152ajpheart005412021rfr_datcr_pub0pubmedurl_verZ3988-2003rfr_idori3Arid3Acrossreforg
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