Intracoronary Electrocardiogram (ECG) and Myonecrosis After Bifurcation Stenting (COSIBRIA&CO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dobrin Vassilev, University National Heart Hospital
ClinicalTrials.gov Identifier:
NCT01268228
First received: December 28, 2010
Last updated: October 14, 2013
Last verified: October 2013
  Purpose

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 the clinical significance of side branch vessel by occluding the blood flow with a 1-minute balloon occlusion. We will also assess whether there is any change in ECG (i.c. and 12-lead surface records) on balloon occlusion and relation with periprocedural myonecrosis.


Condition
Periprocedural Myonecrosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: COronary SIde Branch Residual IschemiA and COllateralization Assessment Study (COSIBRIA & Co Study)

Further study details as provided by University National Heart Hospital:

Primary Outcome Measures:
  • periprocedural myonecrosis [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    Periprocedural myonecrosis - > ULN, 3-5 ULN, >5x ULN; measure - Trponin I & CK-MB


Secondary Outcome Measures:
  • Major cardiovascular events: death, MI, TLR [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • TLR - target lesion revascularization [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The rate of repeated PCI procedures obeing stent + 5mm territory from stent edges during follow up.


Enrollment: 131
Study Start Date: December 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Residual ic ECG ST elevation in SB
Residual ic ECG ST elevation in MB

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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: NCT01268228

Locations
Bulgaria
Medica Core Heart Hopsital
Ruse, Bulgaria, 7000
University National Heart Hospital
Sofia, Bulgaria, 1309
Poland
Central Hospital of the Internal Affairs and Administration Ministry
Warsaw, Poland, 00-517
Sponsors and Collaborators
University National Heart Hospital
Investigators
Principal Investigator: Dobrin Vassilev, MD, PhD University National Heart Hospital
  More Information

No publications provided

Responsible Party: Dobrin Vassilev, Dobrin Vassilev MD, PhD, University National Heart Hospital
ClinicalTrials.gov Identifier: NCT01268228     History of Changes
Other Study ID Numbers: ICECG-12-2010
Study First Received: December 28, 2010
Last Updated: October 14, 2013
Health Authority: Bulgaria: Ethics committee

Keywords provided by University National Heart Hospital:
intracoronary ECG
coronary bifurcation stenosis
side branch compromise
Periprocedural myonecrosis during coronary bifurcation lesion stenting assessed with ic ECG

ClinicalTrials.gov processed this record on August 19, 2014