Coronary Artery DiseaseFIESTANCT01724957
FFR vs. icECG in Coronary Bifurcations
An observational study of Coronary Artery Disease, run by University National Heart Hospital at 2 sites in 2 countries.
Trial summary
The study hypothesis: it is possible to use icECG recorded from regular PCI wire to predict significance of SB ostial stenosis after main vessel stenting in coronary bifurcation lesions. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Intracoronary ECG
- Type of treatment
- Surgery or procedure
- How many people
- 37 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2012to Dec 2020
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Significant, >50% diameter stenosis artery scheduled for stent insertion at the main vessel (Medina types: 1xx, x1x, 11x); * Side branch vessel at least 2.0mm
Who may be able to join
- Subject at least 18 years of age.
- Subject able to verbally confirm understandings of risks, benefits of receiving PCI for true bifurcation lesions, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
- Target main branch lesion(s) located in a native coronary artery with diameter of ≥ 2.5 mm and ≤ 4.5 mm. Target side branch lesion(s) located in a native coronary artery with diameter of ≥ 2.0 mm.
- Target lesion(s) amenable for PCI with balloon angioplasty of the side branch.
Who cannot join
- Subjects with significant ST-T change (≥ 1mm).
- Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- Subjects who refuse to give informed consent.
- Subjects with the following angiographic characteristics: left main coronary artery stenosis, total occlusion before occurrence of SB, lesion of interest located at infarct-related artery.
- Subjects with LVEF < 30%.
- Subjects with moderate or severe degree valvular heart disease or primary cardiomyopathy.
- LBBB, RBBB, atrial fibrillation/flutter with no identifiable isoelectric line.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
- Active, not recruiting
Indiana-Purdue University
Indianapolis, Indiana, IN 46202
Bulgaria1 site, 1 recruiting
- Recruiting
National Heart Hospital
Sofia, 1309
Dobrin Vassilev, MD, PhD, 00359886846550, dobrinv@gmail.com
About this study
Official title: Fractional Flow Reserve Versus Intracoronary ECG for Detection of Post Stenting Ischemia in Side Branch Territory in coronAry Bifurcation Lesions
The study hypothesis: it is possible to use icECG recorded from regular PCI wire to predict significance of SB ostial stenosis after main vessel stenting in coronary bifurcation lesions.
Read the detailed description
The coronary bifurcation lesions pose a therapeutic problem with high rates of periprocedural complications, higher rates of in-stent restenosis and stent thrombosis. These are lesions where stenting is not superior in comparison to balloon angioplasty in regard to side branch. It was demonstrated many times, in literature and in daily practice, that angiographically high grade ostial side branch stenosis is not flow limiting and do not cause ischemia, therefore do not require treatment. From the other side, our own data with MRI before and after bifurcation PCI demonstrated that occurrence of angiographic stenosis more than 70% in diameter is associated with periprocedural myonecrosis in the region of side branch. This fact puts a very important question about the mechanisms of this myonecrosis. If the jailed side branch has no significant flow limiting stenosis, but there is some degree of residual ischemia, which after some period of persistence could lead to myonecrosis, will mean that more aggressive treatment of ostial stenosis is needed. It is interesting that the strategy of treatment is very important, because techniques with second stent implantation (with primary purpose to limit SB ischemia) are associated with higher grade of troponin increase. Of course this is association and not causality, despite that in randomized study (NORDIC I) it was confirmed also.
It is without explanation the fact of rare occurrence of significant (flow limiting, FFR <.75) stenosis appearance (less than 40% in side branches with ostial stenosis more than 75%) and almost 50% periprocedural myonecrosis detected in the side branch areas. One working hypothesis is that stent implantation and related episode of ischemia induces prolonged vasospasm, resulting in prolonged ischemia. Thus, the ostial stenosis could be non-significant as estimated and registered by FFR, but on microcirculatory lever ischemia could persist is small areas for which available flow is not sufficient despite that global regional flow is deemed sufficient. It is also possible that those patients have not enough recruitable collaterals. It is also possible that both factors act together.
Although FFR is useful for assessing the degree of ischemia caused by a coronary lesion, it cannot give information as to whether this ischemia may be clinically significant or not, i.e. whether the ischemia affects a large territory. Therefore, it can be implicated that FFR may not be useful in predicting clinically meaningful ischemia in a specific side branch vessel.
The intracoronary electrocardiography (i.c. ECG) is a very sensitive method for ischemia detection. The i.c. ECG reacts earlier on ischemia; the changes are much more prominent and easy to register. The wire tip could be positioned directly in different regions and thus to "map" regional ischemia. In most of the studies and from our own observations became evident that when surface ECG do not react the i.c. ECG demonstrates significant changes in ST-segment and QRS complex. Moreover, the registration of i.c. ECG is very cheap and needs only an adapter connecting coronary wire end and ECG. An i.c. ECG also can differentiate residual ischemic changes in distal main vessel and side branch as sources of prolonged ischemia, respectively - source of periprocedural myonecrosis.
The objective of this study is to evaluate concordance between icECG findings and FFR findings after stenting main vessel.
- Conditions
- Coronary Artery Disease
- Being tested
- Intracoronary ECG
- Keywords
- Fractional flow reserve,, coronary bifurcation stenosis,, intracoronary ECG,, coronary stent, Coronary bifurcation lesions, icECG
- 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.
Intracoronary ECGProcedure or surgery
Recording of icECG from the tip of PCI guidewire. The wire end is connected through alligator clips to V-lead from surface ECG
| Study group | Role | What they receive |
|---|---|---|
| Patients with coronary bifurcation lesions | Only one group will be studied. The patient will be a slef-reference. Receives: Procedure: Intracoronary ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side branch region ischemia duration
FFR<0.80 at the SB ostium after stenting main vessel in coronary bifurcation lesion; icECG ST-segment elevation >2.0mm; T-wave inversion >3mm; ST-segment depression >2mm, not observed at the beginning of procedure
Measured: Percutaneous coronary intervention procedure time (up to 4h)
Secondary outcomes (4)
Target lesion revascularization
Any revascularization at the territory of previously implanted stent.
Measured: 12 months
Number of patients not alive
Measured: 12 month
Myocardial infarction after hospital discharge
MI according to universal definition of MI - CK-MB > 2xULN +/- symptoms +/- surface ECG changes in at least 2 leads
Measured: 12 months
New onset angina or heart failure symptoms
New onset angina symptoms of at least CCS class II; New onset dyspnea at exertion or at rest
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2016
- Study completionDec 2020 (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
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University National Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dobrin Vassilev, University National Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724957
- Sponsor's protocol ID
- 20120109-05
- Acronym
- FIESTA
- Status last verified
- Aug 2019
- First submitted
- 5 Nov 2012
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional Flow Reserve Versus Intracoronary ECG for Detection of Post Stenting Ischemia in Side Branch Territory in coronAry Bifurcation Lesions
- ClinicalTrials.gov ID
- NCT01724957
- Acronym / sponsor ID
- FIESTA / 20120109-05
- Conditions
- Coronary Artery Disease
- Keywords
- Fractional flow reserve,, coronary bifurcation stenosis,, intracoronary ECG,, coronary stent, Coronary bifurcation lesions, icECG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- University National Heart HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 12 Nov 2012 (estimated)
- 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 study hypothesis: it is possible to use icECG recorded from regular PCI wire to predict significance of SB ostial stenosis after main vessel stenting in coronary bifurcation lesions.
Detailed description
The coronary bifurcation lesions pose a therapeutic problem with high rates of periprocedural complications, higher rates of in-stent restenosis and stent thrombosis. These are lesions where stenting is not superior in comparison to balloon angioplasty in regard to side branch. It was demonstrated many times, in literature and in daily practice, that angiographically high grade ostial side branch stenosis is not flow limiting and do not cause ischemia, therefore do not require treatment. From the other side, our own data with MRI before and after bifurcation PCI demonstrated that occurrence of angiographic stenosis more than 70% in diameter is associated with periprocedural myonecrosis in the region of side branch. This fact puts a very important question about the mechanisms of this myonecrosis. If the jailed side branch has no significant flow limiting stenosis, but there is some degree of residual ischemia, which after some period of persistence could lead to myonecrosis, will mean that more aggressive treatment of ostial stenosis is needed. It is interesting that the strategy of treatment is very important, because techniques with second stent implantation (with primary purpose to limit SB ischemia) are associated with higher grade of troponin increase. Of course this is association and not causality, despite that in randomized study (NORDIC I) it was confirmed also.
It is without explanation the fact of rare occurrence of significant (flow limiting, FFR <.75) stenosis appearance (less than 40% in side branches with ostial stenosis more than 75%) and almost 50% periprocedural myonecrosis detected in the side branch areas. One working hypothesis is that stent implantation and related episode of ischemia induces prolonged vasospasm, resulting in prolonged ischemia. Thus, the ostial stenosis could be non-significant as estimated and registered by FFR, but on microcirculatory lever ischemia could persist is small areas for which available flow is not sufficient despite that global regional flow is deemed sufficient. It is also possible that those patients have not enough recruitable collaterals. It is also possible that both factors act together.
Although FFR is useful for assessing the degree of ischemia caused by a coronary lesion, it cannot give information as to whether this ischemia may be clinically significant or not, i.e. whether the ischemia affects a large territory. Therefore, it can be implicated that FFR may not be useful in predicting clinically meaningful ischemia in a specific side branch vessel.
The intracoronary electrocardiography (i.c. ECG) is a very sensitive method for ischemia detection. The i.c. ECG reacts earlier on ischemia; the changes are much more prominent and easy to register. The wire tip could be positioned directly in different regions and thus to "map" regional ischemia. In most of the studies and from our own observations became evident that when surface ECG do not react the i.c. ECG demonstrates significant changes in ST-segment and QRS complex. Moreover, the registration of i.c. ECG is very cheap and needs only an adapter connecting coronary wire end and ECG. An i.c. ECG also can differentiate residual ischemic changes in distal main vessel and side branch as sources of prolonged ischemia, respectively - source of periprocedural myonecrosis.
The objective of this study is to evaluate concordance between icECG findings and FFR findings after stenting main vessel.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with coronary bifurcation lesions | – | Procedure: Intracoronary ECGOnly one group will be studied. The patient will be a slef-reference. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Significant, >50% diameter stenosis artery scheduled for stent insertion at the main vessel (Medina types: 1xx, x1x, 11x); * Side branch vessel at least 2.0mm
Key inclusion criteria (4 listed)
- Subject at least 18 years of age.
- Subject able to verbally confirm understandings of risks, benefits of receiving PCI for true bifurcation lesions, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
- Target main branch lesion(s) located in a native coronary artery with diameter of ≥ 2.5 mm and ≤ 4.5 mm. Target side branch lesion(s) located in a native coronary artery with diameter of ≥ 2.0 mm.
- Target lesion(s) amenable for PCI with balloon angioplasty of the side branch.
Key exclusion criteria (7 listed)
- Subjects with significant ST-T change (≥ 1mm).
- Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- Subjects who refuse to give informed consent.
- Subjects with the following angiographic characteristics: left main coronary artery stenosis, total occlusion before occurrence of SB, lesion of interest located at infarct-related artery.
- Subjects with LVEF < 30%.
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 |
|---|---|---|
| Intracoronary ECGRecording of icECG from the tip of PCI guidewire. The wire end is connected through alligator clips to V-lead from surface ECG | Procedure or surgery | Patients with coronary bifurcation lesions |
Primary outcome
Side branch region ischemia duration
Time frame: Percutaneous coronary intervention procedure time (up to 4h)
FFR<0.80 at the SB ostium after stenting main vessel in coronary bifurcation lesion; icECG ST-segment elevation >2.0mm; T-wave inversion >3mm; ST-segment depression >2mm, not observed at the beginning of procedure
4 secondary outcomes
Target lesion revascularization
Time frame: 12 months
Number of patients not alive
Time frame: 12 month
Myocardial infarction after hospital discharge
Time frame: 12 months
New onset angina or heart failure symptoms
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
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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.
2 sites in 2 countries: 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 University National Heart Hospital at 2 sites in 2 countries.
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 4 inclusion and 7 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 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Bulgaria. 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 Dobrin Vassilev, MD, PhD (00359886846550, dobrinv@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side branch region ischemia duration (time frame: Percutaneous coronary intervention procedure time (up to 4h)). 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 20 Aug 2019.