Ignite Creation Date:
2024-05-06 @ 5:45 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05421169
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2022-06-05
Brief Title:
Diastolic Hyperemia-Free Ratio in Patients With CAD
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
Invasive funCtional assEssment Using Diastolic HypEremia-Free RATio in Patient With Coronary Artery Disease a Prospective Observation Study ICE-HEAT
Status:
COMPLETED
Status Verified Date:
2024-03
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:
ICE-HEAT
Brief Summary:
The investigators aimed to identify the value of concordance between the diastolic hyperemia-free ratio DFR and fractional flow reserve FFR during pre-interventional and post-interventional period using a 0014 COMET II Pressure Guidewire
Detailed Description:
The physiologic assessment of coronary artery disease and ischemia-guided percutaneous coronary intervention PCI has become a standard practice for patients with coronary artery disease Fractional flow reserve FFR represents hyperemic flow limitation caused by an epicardial coronary stenosis and its clinical usefulness has been proven by many clinical studies However the FFR is limited to clinical use despite the fact that it is recommended by the guideline due to the inconvenience of patients using medications used to induce maximum hyperemia and the need for additional procedure time Recently a physiologic index which does not require hyperemia instantaneous wave free ratio iFR was introduced and recent trials showed non-inferiority of iFR-guided strategy for 1-year clinical outcome compared with FFR-guided strategy Recently not only iFR but also various intravascular pressure measurement techniques have been developed one of which is diastolic hyperemia-free ratio DFR DFR uses the mean PdPa calculated over the period in diastole defined as that during which arterial pressure is negatively sloped and below the mean arterial pressure DFR showed equivalence as compared to gold standard FFR in the discrimination of non-culprit lesions requiring revascularization in patients with NSTEMI In the case of DFR there is no issue in terms of safety because it is conducted in the same way as iFR but there are not many studies on the validation between DFR and FFR Therefore the present study aimed to identify the quality of concordance between DFR and FFR determine the features associated with discrepancies in DFR and FFR
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