FFR vs. icECG in Coronary Bifurcations (FIESTA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University National Heart Hospital
Sponsor:
Information provided by (Responsible Party):
Dobrin Vassilev, University National Heart Hospital
ClinicalTrials.gov Identifier:
NCT01724957
First received: November 5, 2012
Last updated: October 13, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Procedure: Intracoronary ECG

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fractional Flow Reserve Versus Intracoronary ECG for Detection of Post Stenting Ischemia in Side Branch Territory in coronAry Bifurcation Lesions

Further study details as provided by University National Heart Hospital:

Primary Outcome Measures:
  • Side branch region ischemia duration [ Time Frame: Percutaneous coronary intervention procedure time (up to 4h) ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Target lesion revascularization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Any revascularization at the territory of previously implanted stent.

  • Number of patients not alive [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  • Myocardial infarction after hospital discharge [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    MI according to universal definition of MI - CK-MB > 2xULN +/- symptoms +/- surface ECG changes in at least 2 leads

  • New onset angina or heart failure symptoms [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    New onset angina symptoms of at least CCS class II; New onset dyspnea at exertion or at rest


Other Outcome Measures:
  • Periprocedural myonecrosis - extent of post PCI enzyme elevation [ Time Frame: 48h ] [ Designated as safety issue: Yes ]
    Troponin I elevation 1-3; 3-5; >5 x ULN Creatin phospho kinase MB fraction elevation 1-3; 3-5; >5 x ULN


Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with coronary bifurcation lesions
Only one group will be studied. The patient will be a slef-reference.
Procedure: Intracoronary ECG
Recording of icECG from the tip of PCI guidewire. The wire end is connected through alligator clips to V-lead from surface ECG

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724957

Contacts
Contact: Dobrin Vassilev, MD, PhD 00359886846550 dobrinv@gmail.com

Locations
United States, Indiana
Indiana-Purdue University Active, not recruiting
Indianapolis, Indiana, United States, IN 46202
Bulgaria
National Heart Hospital Recruiting
Sofia, Bulgaria, 1309
Contact: Dobrin Vassilev, MD, PhD    00359886846550    dobrinv@gmail.com   
Sponsors and Collaborators
University National Heart Hospital
  More Information

No publications provided

Responsible Party: Dobrin Vassilev, Dobrin Vassilev MD, PhD, University National Heart Hospital
ClinicalTrials.gov Identifier: NCT01724957     History of Changes
Other Study ID Numbers: 20120109-05
Study First Received: November 5, 2012
Last Updated: October 13, 2013
Health Authority: Bulgaria: Ethics committee

Keywords provided by University National Heart Hospital:
Fractional flow reserve,
coronary bifurcation stenosis,
intracoronary ECG,
coronary stent
Coronary bifurcation lesions
icECG

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014