Diastolic Hyperemia-Free Ratio in Patients With CAD (ICE-HEAT)

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

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Coronary Stenosis
• Intervention / Treatment: Diagnostic test: diastolic hyperemia-free ratio (DFR)

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.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

• Study Contact: Name: Yongcheol Kim, MD, Phd; Phone Number: +82-031-5189-8967; Email: yongcheol@yuhs.ac
• Study Contact Backup: Name: Ji Woong Roh, MD, PhD; Phone Number: +82-031-5189-8792; Email: NOMGALDA@yuhs.ac

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Yongin, Gyeonggi-do, Korea, Republic of, 16995
      • Yongin Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Comparison of the delta value (Δ 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
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
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

Collaborators and Investigators

• Sponsor: Yonsei University
• Collaborators: Boston Scientific Corporation; Severance Hospital
• Investigators: Principal Investigator: Yongcheol Kim, MD, PhD, Yongin Severance Hopistal

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2022
• Primary Completion (Actual): February 21, 2024
• Study Completion (Actual): March 7, 2024

Study Registration Dates

• First Submitted: June 5, 2022
• First Submitted That Met QC Criteria: June 12, 2022
• First Posted (Actual): June 16, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: coronary artery disease; FFR; DFR
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Hyperemia; Coronary Stenosis
• Other Study ID Numbers: 9-2022-0047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No