Clinical trial NCT05421169: Diastolic Hyperemia-Free Ratio in Patients With CAD
Official title: Invasive funCtional assEssment Using Diastolic HypEremia-Free RATio in Patient With Coronary Artery Disease: a Prospective Observation Study (ICE-HEAT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Stenosis
Coronary Artery Disease
Keywords: coronary artery disease
FFR
DFR
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: Severance Hospital
name: Boston Scientific Corporation
First posted: 2022-06-16
Enrollment: 300
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients of stable angina pectoris including silent ischemic heart disease and 50\~90% stenosis of coronary artery

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 0.014" 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 Pd/Pa 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.

Eligibility criteria: Inclusion Criteria:

* Patients, ≥ 19 years of age, who are diagnosed with stable angina pectoris including silent ischemic heart disease and 50\~90% stenosis of the coronary artery.
* Acute coronary syndrome patients with multivessel disease who have 50\~90% stenosis of a non-culprit vessel on coronary angiography.

Exclusion Criteria:

* Patients with acute coronary syndrome and single vessel disease.
* Patients with hypersensitivity or contraindication to antiplatelet treatment.
* Female of childbearing potential, who possibly plan to become pregnant any time after enrollment into this study.
* Patients with a life expectancy shorter than 1 year.

Primary outcomes:
measure: Comparison of pre-interventional value between DFR <=0.89 and FFR <=0.80
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Comparison of the value between DFR <=0.89 and Pd/Pa <=0.92
timeFrame: through study completion, an average of 1 year
measure: Comparison of post-interventional value between DFR >=0.89 and FFR >=0.80 when DFR/FFR-guided PCI is performed.
timeFrame: through study completion, an average of 1 year
measure: Comparison of the delta value (Δ post-interventional - pre-interventional value) between DFR and FFR.
timeFrame: through study completion, an average of 1 year
measure: Discordance factors between DFR >=0.89 and FFR >=0.80
timeFrame: through study completion, an average of 1 year
measure: Mortality within 30 days
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Yongin
country: Korea, Republic of
facility: Yongin Severance Hospital
state: Gyeonggi-do
Study officials:
affiliation: Yongin Severance Hopistal
name: Yongcheol Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: