Coronary StenosisICE-HEATNCT05421169
Diastolic Hyperemia-Free Ratio in Patients With CAD
An observational study of Coronary Stenosis and Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Stenosis, Coronary Artery Disease
- What is being tested?
- diastolic hyperemia-free ratio (DFR)
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Aug 2022to 7 Mar 2024
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Adult, Older adult
Study population: The patients of stable angina pectoris including silent ischemic heart disease and 50~90% stenosis of coronary artery
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Coronary Stenosis, Coronary Artery Disease
- Being tested
- diastolic hyperemia-free ratio (DFR)
- Keywords
- coronary artery disease, FFR, DFR
- Medical subject headings
- Coronary Stenosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diastolic hyperemia-free ratio (DFR)Diagnostic test
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
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
Measured: 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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start23 Aug 2022
- Primary completion21 Feb 2024
- Study completion7 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary StenosisStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- Severance Hospital, Boston Scientific Corporation
- Responsible party
- Principal investigator, Yongcheol Kim, Yonsei University
- Investigators
- Yongcheol Kim, MD, PhD, Principal investigator, Yongin Severance Hopistal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421169
- Sponsor's protocol ID
- 9-2022-0047
- Acronym
- ICE-HEAT
- Status last verified
- Mar 2024
- First submitted
- 5 Jun 2022
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Publications
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.
PubMed 40206008
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invasive funCtional assEssment Using Diastolic HypEremia-Free RATio in Patient With Coronary Artery Disease: a Prospective Observation Study (ICE-HEAT)
- ClinicalTrials.gov ID
- NCT05421169
- Acronym / sponsor ID
- ICE-HEAT / 9-2022-0047
- Conditions
- Coronary Stenosis, Coronary Artery Disease
- Keywords
- coronary artery disease, FFR, DFR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- Severance Hospital, Boston Scientific Corporation
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 21 Feb 2024 (actual)
- Study completion
- 7 Mar 2024 (actual)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The patients of stable angina pectoris including silent ischemic heart disease and 50~90% stenosis of coronary artery
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Diagnostic test | – |
Primary outcome
Comparison of pre-interventional value between DFR <=0.89 and FFR <=0.80
Time frame: through study completion, an average of 1 year
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.
5 secondary outcomes
Comparison of the value between DFR <=0.89 and Pd/Pa <=0.92
Time frame: 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.
Time frame: through study completion, an average of 1 year
Comparison of the delta value (Δ post-interventional - pre-interventional value) between DFR and FFR.
Time frame: through study completion, an average of 1 year
Discordance factors between DFR >=0.89 and FFR >=0.80
Time frame: through study completion, an average of 1 year
Mortality within 30 days
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Derived from this study: PubMed 40206008Roh 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.
- Individual participant dataSharing planned: Undecided. undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yongcheol Kim, MD, PhD principal investigator
Yongin Severance Hopistal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Stenosis and Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of pre-interventional value between DFR <=0.89 and FFR <=0.80 (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05421169, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.