NCT04061525

Motion and IntraCoronary Ecg Ischemia Development Study (MICE)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: University National Heart Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

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 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

Conditions

• Ischaemic Heart Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-02-01
• Primary completion: 2022-01-01
• Completion: 2024-01-01
• First posted: 2019-08-19
• Last updated: 2019-08-19

Locations

1 site across 1 country: Bulgaria