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)
1 other identifier
observational
300
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2022
CompletedFirst Posted
Study publicly available on registry
June 16, 2022
CompletedStudy Start
First participant enrolled
August 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 21, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 7, 2024
CompletedMarch 15, 2024
March 1, 2024
1.5 years
June 5, 2022
March 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Comparison of the value between DFR <=0.89 and Pd/Pa <=0.92
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.
through study completion, an average of 1 year
Comparison of the delta value (Δ post-interventional - pre-interventional value) between DFR and FFR.
through study completion, an average of 1 year
Discordance factors between DFR >=0.89 and FFR >=0.80
through study completion, an average of 1 year
Mortality within 30 days
through study completion, an average of 1 year
Interventions
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
Eligibility Criteria
The patients of stable angina pectoris including silent ischemic heart disease and 50\~90% stenosis of coronary artery
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yonsei Universitylead
- Severance Hospitalcollaborator
- Boston Scientific Corporationcollaborator
Study Sites (1)
Yongin Severance Hospital
Yongin, Gyeonggi-do, 16995, South Korea
Related Publications (1)
Roh JW, Lee OH, Kim Y, Heo SJ, Im E, Cho DK. Diastolic Hyperemia-Free Ratio in Patients With Coronary Artery Disease: A Prospective Observational Study. Korean Circ J. 2025 Jul;55(7):600-610. doi: 10.4070/kcj.2024.0351. Epub 2025 Feb 17.
PMID: 40206008DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yongcheol Kim, MD, PhD
Yongin Severance Hopistal
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Month
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Associate Professor
Study Record Dates
First Submitted
June 5, 2022
First Posted
June 16, 2022
Study Start
August 23, 2022
Primary Completion
February 21, 2024
Study Completion
March 7, 2024
Last Updated
March 15, 2024
Record last verified: 2024-03