Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06261866
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2024-02-07
Brief Title:
Multimodality Imaging and Functional Lesion Assessment in Intermediate Coronary Stenosis in Chronic Coronary Syndrome
Sponsor:
Medical University of Warsaw
Organization:
Medical University of Warsaw
Study Overview
Official Title:
Multimodality Imaging and Functional Lesion Assessment in Intermediate Grade Coronary Stenosis in Chronic Coronary Syndrome MultiInter-CCS Study
Status:
RECRUITING
Status Verified Date:
2024-02
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:
MultiInter-CCS
Brief Summary:
The aim of this prospective investigator-initiated study is to evaluate the diagnostic accuracy and correlations between functional indices fractional flow reserve FFR and morphometric indices luminal and qualitative parameters assessed by optical coherence tomography OCT including minimal lumen area plaque type presence of thin cap fibroatheroma among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis
Detailed Description:
This is a prospective single center non-randomized single-arm investigator-initiated study evaluating diagnostic accuracy and correlations between functional indices fractional flow reserve FFR and morphometric indices luminal and qualitative parameters evaluated by OCT including minimal lumen area plaque stratification into fibrotic calcific lipidic plaque or thin cap fibroatheroma among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis
The additional objectives include evaluation of the impact of age sex diabetes mellitus renal dysfunction on the assocation between functional and morphometric indices of coronary stenosis
We hypothesized that in patients with intermediate grade coronary stenosis in chronic coronary syndorme there is a positive correlation between the functional parameters and the morphometric parameters of cornary stenosis
The additional objectives include evaluation of the impact of age sex diabetes mellitus renal dysfunction on the assocation between functional and morphometric indices of coronary stenosis
We hypothesized that in patients with intermediate grade coronary stenosis in chronic coronary syndorme there is a positive correlation between the functional parameters and the morphometric parameters of cornary stenosis
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