Status:
UNKNOWN
Motion and IntraCoronary Ecg Ischemia Development Study (MICE)
Lead Sponsor:
University National Heart Hospital
Conditions:
Ischaemic Heart Disease
Eligibility:
All Genders
18-90 years
Brief Summary
The concept of the "ischemic cascade" is generally accepted hypothesis, according to which whenever ischemia of the myocardium occurs there is a consequence of events, that always occur in a given ord...
Detailed Description
The development of an ischemic event, whether silent or painful, represents the cumulative impact of a sequence of pathophysiologic events. Each ischemic episode is initiated by an imbalance between m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04061525
Start Date
February 1 2019
End Date
January 1 2024
Last Update
August 19 2019
Active Locations (1)
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1
Alexandrovska University Hospital
Sofia, Bulgaria