Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

FFR vs. icECG in Coronary Bifurcations (FIESTA)

18 augustus 2019 bijgewerkt door: Dobrin Vassilev, University National Heart Hospital

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.

Studie Overzicht

Toestand

Onbekend

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Verwacht)

37

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

      • Sofia, Bulgarije, 1309
        • Werving
        • National Heart Hospital
        • Contact:
    • Indiana
      • Indianapolis, Indiana, Verenigde Staten, IN 46202
        • Actief, niet wervend
        • Indiana-Purdue University

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 90 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

  • 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

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Patients with coronary bifurcation lesions
Only one group will be studied. The patient will be a slef-reference.
Recording of icECG from the tip of PCI guidewire. The wire end is connected through alligator clips to V-lead from surface ECG

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Side branch region ischemia duration
Tijdsspanne: 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
Percutaneous coronary intervention procedure time (up to 4h)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Doel laesie revascularisatie
Tijdsspanne: 12 maanden
Elke revascularisatie op het grondgebied van een eerder geïmplanteerde stent.
12 maanden
Nieuwe symptomen van angina pectoris of hartfalen
Tijdsspanne: 12 maanden
Nieuwe symptomen van angina pectoris van ten minste CCS klasse II; Nieuw optredende dyspnoe bij inspanning of in rust
12 maanden
Number of patients not alive
Tijdsspanne: 12 month
12 month
Myocardial infarction after hospital discharge
Tijdsspanne: 12 months
MI according to universal definition of MI - CK-MB > 2xULN +/- symptoms +/- surface ECG changes in at least 2 leads
12 months

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Periprocedural myonecrosis - extent of post PCI enzyme elevation
Tijdsspanne: 48h
Troponin I elevation 1-3; 3-5; >5 x ULN Creatin phospho kinase MB fraction elevation 1-3; 3-5; >5 x ULN
48h

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2012

Primaire voltooiing (Werkelijk)

1 december 2016

Studie voltooiing (Verwacht)

1 december 2020

Studieregistratiedata

Eerst ingediend

5 november 2012

Eerst ingediend dat voldeed aan de QC-criteria

9 november 2012

Eerst geplaatst (Schatting)

12 november 2012

Updates van studierecords

Laatste update geplaatst (Werkelijk)

20 augustus 2019

Laatste update ingediend die voldeed aan QC-criteria

18 augustus 2019

Laatst geverifieerd

1 augustus 2019

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Coronaire hartziekte

Klinische onderzoeken op Intracoronary ECG

3
Abonneren