Coronary Artery DiseaseNCT06075173
Resting Full-cycle Ratio in Side Branch
An observational study of Coronary Artery Disease, run by Sejong General Hospital at 1 site in South Korea.
Trial summary
The goal of this observational study is to evaluate diagnostic performance of resting full-cycle rate (RFR) in side branch lesion. We aims to evaluate whether the diagnostic performance of RFR in the side branch lesion is non-inferior compared to that in the main vessel lesion RFR and FFR measurements will be… Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Resting full-cycle ration (RFR) measurments
- How many people
- 286 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Jan 2020to 31 Dec 2024
- How long will I take part?
- 6 Months
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with side branch lesion, who need functional evaluation
Who may be able to join
- Patients with side branch lesion, who need functional evaluation
Who cannot join
- Severe LV systolic dysfunction (LVEF <30%)
- Culprit vessel in acute coronary syndrome
- Donor vessel to supply chronic total occlusion lesion of non-target vessel
- Symptomatic valvular heart disease or cardiomyopathy
- Too much overlapping or severe tortuosity to disrupt quantitative coronary analysis
- Previous bypass surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Sejong General Hospital
Bucheon-si, Gyeonggi-do, 14574
Hyun-Jong Lee, MD, PhD, 82-10-6217-9315, untouchables00@hanmail.net
About this study
Official title: PRospEctive Evaluation of DIagnostiC Performances of resTing Full-cycle rAtio in Coronary Bifurcation LEsion (PREDICTABLE Study)
The goal of this observational study is to evaluate diagnostic performance of resting full-cycle rate (RFR) in side branch lesion.
We aims to evaluate whether the diagnostic performance of RFR in the side branch lesion is non-inferior compared to that in the main vessel lesion RFR and FFR measurements will be performed to define functional significance in patients with side branch lesion with or without main vessel lesion
Read the detailed description
The presence of myocardial ischemia is the most important prognostic indicator in patients with coronary artery disease. Pressure-based functional assessment has been recommended to assess the presence of myocardial ischemia due to low accuracy of image-based assessment in intermediate coronary artery disease. Selective revascularization for only ischemia-producing lesion with fractinal flow reserve(FFR) guidance proved to decrease adverse cardiac events and avoid unnecessary coronary stenting, compared to angiography-guided revascularization. Therefore, Current guidelines strongly recommend FFR measurement for the assessment of the functional severity of moderate stenosis of a culprit lesion in stable coronary artery disease, and non-culprit lesion in acute coronary syndrome. However, it's clinical adaption in a real world was still very low, because of the need of pressure wire and hyperemic agent. Instantaneous flow ratio (iFR), which the ratio of distal coronary artery pressure to aortic pressure during wave-free period at rest, had a high diagnostic accuracy to define functional significance without need of adenosine. According to two large randomized trials, iFR-guided coronary revascularization proved to be non-inferior to FFR-guided revascularization with respect to one-year risk of major adverse cardiac events. Recently, new adenosine-free index, called as a resting full-cycle ratio (RFR), which is completely independent of the ECG and irrespective of systole or diastole has been validated to detect myocardial ischemia. RFR is not limited by sensitive land marking of components of the pressure waveform unlike iFR, and is diagnostically equivalent to iFR.
This novel physiologic index without need of adenosine have a potential to widely spread of functional assessment for coronary artery stenosis in daily clinical practice, and simplify procedure in complex coronary artery disease. Therefore, we sought to investigate diagnostic performance of this novel physiologic index to define myocardial ischemia in coronary bifurcation lesion, which is one of complex lesion subset.
- Conditions
- Coronary Artery Disease
- Being tested
- Resting full-cycle ration (RFR) measurments
- Keywords
- bifurcation lesion, physiologic assessment
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resting full-cycle ration (RFR) measurmentsDiagnostic test
Also called fractional flow ratio (FFR) measurments
RFR and FFR measurements in main vessel and side branch lesions
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic sensitivity of RFR in side branch lesions
diagnostic sensitivity of RFR to predict FFR < 0.80
Measured: during index coronary angiography
Secondary outcomes (1)
Specificity, positive predictability, negative predictability, diagnostic accuracy, area under the curve (AUC) value in side branch
diagnostic performances of RFR to predict FFR < 0.80
Measured: during index coronary angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start8 Jan 2020
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- 286 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Sejong General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Soon Chun Hyang University, Keimyung University Dongsan Medical Center, Hanyang University Seoul Hospital
- Responsible party
- Principal investigator, Hyun Jong Lee, Sejong General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075173
- Sponsor's protocol ID
- PREDICTABLE Version 3.5
- Status last verified
- Oct 2023
- First submitted
- 3 Oct 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRospEctive Evaluation of DIagnostiC Performances of resTing Full-cycle rAtio in Coronary Bifurcation LEsion (PREDICTABLE Study)
- ClinicalTrials.gov ID
- NCT06075173
- Acronym / sponsor ID
- PREDICTABLE Version 3.5
- Conditions
- Coronary Artery Disease
- Keywords
- bifurcation lesion, physiologic assessment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Sejong General HospitalUniversity, hospital or other
- Collaborators
- Soon Chun Hyang University, Keimyung University Dongsan Medical Center, Hanyang University Seoul Hospital
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Oct 2023 (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 goal of this observational study is to evaluate diagnostic performance of resting full-cycle rate (RFR) in side branch lesion.
We aims to evaluate whether the diagnostic performance of RFR in the side branch lesion is non-inferior compared to that in the main vessel lesion RFR and FFR measurements will be performed to define functional significance in patients with side branch lesion with or without main vessel lesion
Detailed description
The presence of myocardial ischemia is the most important prognostic indicator in patients with coronary artery disease. Pressure-based functional assessment has been recommended to assess the presence of myocardial ischemia due to low accuracy of image-based assessment in intermediate coronary artery disease. Selective revascularization for only ischemia-producing lesion with fractinal flow reserve(FFR) guidance proved to decrease adverse cardiac events and avoid unnecessary coronary stenting, compared to angiography-guided revascularization. Therefore, Current guidelines strongly recommend FFR measurement for the assessment of the functional severity of moderate stenosis of a culprit lesion in stable coronary artery disease, and non-culprit lesion in acute coronary syndrome. However, it's clinical adaption in a real world was still very low, because of the need of pressure wire and hyperemic agent. Instantaneous flow ratio (iFR), which the ratio of distal coronary artery pressure to aortic pressure during wave-free period at rest, had a high diagnostic accuracy to define functional significance without need of adenosine. According to two large randomized trials, iFR-guided coronary revascularization proved to be non-inferior to FFR-guided revascularization with respect to one-year risk of major adverse cardiac events. Recently, new adenosine-free index, called as a resting full-cycle ratio (RFR), which is completely independent of the ECG and irrespective of systole or diastole has been validated to detect myocardial ischemia. RFR is not limited by sensitive land marking of components of the pressure waveform unlike iFR, and is diagnostically equivalent to iFR.
This novel physiologic index without need of adenosine have a potential to widely spread of functional assessment for coronary artery stenosis in daily clinical practice, and simplify procedure in complex coronary artery disease. Therefore, we sought to investigate diagnostic performance of this novel physiologic index to define myocardial ischemia in coronary bifurcation lesion, which is one of complex lesion subset.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with side branch lesion, who need functional evaluation
Key inclusion criteria (1 listed)
- Patients with side branch lesion, who need functional evaluation
Key exclusion criteria (6 listed)
- Severe LV systolic dysfunction (LVEF <30%)
- Culprit vessel in acute coronary syndrome
- Donor vessel to supply chronic total occlusion lesion of non-target vessel
- Symptomatic valvular heart disease or cardiomyopathy
- Too much overlapping or severe tortuosity to disrupt quantitative coronary analysis
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 |
|---|---|---|
| Resting full-cycle ration (RFR) measurmentsAlso: fractional flow ratio (FFR) measurmentsRFR and FFR measurements in main vessel and side branch lesions | Diagnostic test | – |
Primary outcome
diagnostic sensitivity of RFR in side branch lesions
Time frame: during index coronary angiography
diagnostic sensitivity of RFR to predict FFR < 0.80
1 secondary outcome
Specificity, positive predictability, negative predictability, diagnostic accuracy, area under the curve (AUC) value in side branch
Time frame: during index coronary angiography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Recruiting
Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
Stable Angina, Multivessel Coronary Artery Disease
Not yet recruitingPhase 3
Efficacy of Lipoic Acid on Chronic Ischemic Heart Failure Patients
Heart Failure Due to Coronary Artery Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
Prognostic Value of Functional-Nutritional Status in Older Adults With Acute Coronary Syndrome
Acute Coronary Syndromes (ACS)
RecruitingObservational study
Cardiovascular Acoustics for Early Disease Detection
Valvular Heart Disease, Coronary Artery Disease
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.
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 Artery Disease, run by Sejong General Hospital 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun-Jong Lee, MD, PhD (82-10-6217-9315, untouchables00@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic sensitivity of RFR in side branch lesions (time frame: during index coronary angiography). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2023.