Diastolic Hyperemia-Free Ratio in Patients With CAD

Coronary Artery Disease Clinical Trial

— ICE-HEAT  

Official title:

Invasive funCtional assEssment Using Diastolic HypEremia-Free RATio in Patient With Coronary Artery Disease: a Prospective Observation Study (ICE-HEAT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05421169
• Other study ID #: 9-2022-0047
• Status: Completed
• Start date: August 23, 2022
• Est. completion date: March 7, 2024

Study information

• Verified date: March 2024
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 7, 2024
• Est. primary completion date: February 21, 2024
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Stenosis
• Hyperemia
• Myocardial Ischemia

Intervention

Diagnostic Test:
• diastolic hyperemia-free ratio (DFR)
diastolic hyperemia-free ratio 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

Locations

Country	Name	City	State
Korea, Republic of	Yongin Severance Hospital	Yongin	Gyeonggi-do

Sponsors (3)

Lead Sponsor	Collaborator
Yonsei University	Boston Scientific Corporation, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of pre-interventional value between DFR <=0.89 and FFR <=0.80	Efficacy and correlation of two invasive indexes of functional assessment by intracoronary pressure guidance in intermediate lesions with a cut-off point to defer the treatment of FFR< = 0.80 (with intravenous sigmart) and DFR < = 0.89.	through study completion, an average of 1 year
Secondary	Comparison of the value between DFR <=0.89 and Pd/Pa <=0.92	Efficacy and correlation of two invasive indexes of functional assessment by intracoronary pressure guidance in intermediate lesions with a cut-off point to defer the treatment of and DFR < = 0.89 and Pd/Pa <=0.92.; Pd/Pa (resting distal to aortic coronary pressure) was evaluated as the ratio of mean aortic pressure (Pa) to mean distal coronary arterial pressure (Pd), After getting the Pd/Pa value, investigators performed DFR computation considering average Pd/Pa during the period between Pa less than mean Pa ending at systole and calculated using auto-mated algorithms (Boston scientific) acting during a minimum of three beats.	through study completion, an average of 1 year
Secondary	Comparison of post-interventional value between DFR >=0.89 and FFR >=0.80 when DFR/FFR-guided PCI is performed.	When the patients refered to PCI due to FFR <=0.80 or DFR <=0.89 for coronary stenotic lesion, investigators compared with post-interventional value between DFR and FFR after PCI.	through study completion, an average of 1 year
Secondary	Comparison of the delta value (? post-interventional - pre-interventional value) between DFR and FFR.	When PCI will be conduced, the comparison of the delta value between pre and post value of DFR and FFR will be measured.	through study completion, an average of 1 year
Secondary	Discordance factors between DFR >=0.89 and FFR >=0.80	After assessment of DFR and FFR, the investigators collected the date of mismatch between DFR >=0.89 and FFR >=0.80 and analyzed the discordance factors between DFR >=0.89 and FFR >=0.80	through study completion, an average of 1 year
Secondary	Mortality within 30 days	umber of participants who died due to sudden cardiac arrest, sudden death due to acute MI and death due to heart failure or cardiogenic shock within 30 days	through study completion, an average of 1 year