Motion and IntraCoronary Ecg Ischemia Development Study (MICE)

Ischaemic Heart Disease Clinical Trial

— MICE  

Official title:

Motion and IntraCoronary Ecg Ischemia Development Study (MICE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04061525
• Other study ID #: MICE-102019
• Status: Recruiting
• Start date: February 1, 2019
• Est. completion date: January 2024

Study information

• Verified date: August 2019
• Source: University National Heart Hospital
• Contact: Dobrin Vassilev
• Phone: +359886846550
• Email: dobrinv[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 order - diastolic dysfunction first, followed by systolic dysfunction, then changes on electrocardiogram (ECG) and finally chest pain sensation. The occurrence of every next stage of cascade means more severe ischemia and respectively - more severe myocardial damage. We propose that mechanical and electrical changes in the myocardium during ischemia appear simultaneously.

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 myocardial oxygen supply and demand that may ultimately be manifested as angina pectoris. The ischaemic cascade is the concept that progressive myocardial oxygen supply-demand mismatch causes a consistent sequence of events, starting with metabolic alterations and followed sequentially by myocardial perfusion abnormalities, wall motion abnormalities, ECG changes, and angina. This concept would suggest that investigations that detect expressions of ischaemia earlier in the cascade should be more sensitive tests of ischaemia than those that detect expressions appearing later in the cascade.Visualization of a regional decrease in the systolic movement of the endocardium and a decrease in myocardial thickening are the main principles for the diagnosis of myocardial damage. However, the concept of ischaemic cascade is entirely based on clinical observations. It is not clear, which changes (mechanical or electrical) appear first during an episode of ischemia and which are prognostically more important. The objective of this study is to compare ischemic cascade towards ischemic constellation regarding beginning, duration and sequence of the electric, kinetic and haemodynamic signs of ischemia by FFR, icECG and wall motion abnormalities sign (M-sign - deformation and shortening of the wire tip) in patients with coronary bifurcation stenosis

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2024
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischaemic Heart Disease
• Ischemia
• Myocardial Ischemia

Intervention

Procedure:
• Percutaneous coronary intervention with FFR measurement and intracoronary ECG registration
Measurement of fractional flow reserve (FFR), registration of intracoronary ECG and radioscopic registration of wire tip movement in the main and in the side branch in the beginning, at the end and during every step of coronary bifurcation percutaneous intervention.

Locations

Country	Name	City	State
Bulgaria	Alexandrovska University Hospital	Sofia

Sponsors (1)

Lead Sponsor	Collaborator
University National Heart Hospital

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Periprocedural myonecrosis - extent of post PCI enzyme elevation	Troponin I elevation 1-3; 3-5; >5 x ULN Creatin phosphokinase MB fraction elevation 1-3; 3-5; >5 x ULN	48 hours
Primary	Side branch region ischemia	Beginning, duration, sequence of the electric, kinetic and haemodynamic signs of ischemia, comparison between ischemic cascade and constellation.	Percutaneous coronary intervention procedure time (up to 4 hours)
Secondary	Target lesion revascularization	Any revascularization at the territory of previously intervention	12 months
Secondary	Number of patients not alive	Number of patients not alive	12 months
Secondary	Myocardial infarction after hospital discharge	Myocardial infarction according to universal definition of MI - CK-MB > 2xULN +/- symptoms +/- surface ECG changes in at least 2 leads	12 months
Secondary	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	12 months