Motion and IntraCoronary Ecg Ischemia Development Study (MICE)

NCT04061525 | Unknown

• 1 other identifier: MICE-102019
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Ischaemic Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Target lesion revascularization

  12 months

• Number of patients not alive

  12 months

• Myocardial infarction after hospital discharge

  12 months

• New onset angina or heart failure symptoms

  12 months

Other Outcomes (1)

• Periprocedural myonecrosis - extent of post PCI enzyme elevation

  48 hours

Study Arms (1)

Patients with coronary bifurcation lesions

Patients from 18 to 90-years old with coronary bifurcation lesions with significant \>50% diameter stenosis artery scheduled for intervention of the main vessel (Medina types: 1x1, x11, 111)

Procedure: Percutaneous coronary intervention with FFR measurement and intracoronary ECG registration

Interventions

Percutaneous coronary intervention with FFR measurement and intracoronary ECG registration PROCEDURE

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.

Patients with coronary bifurcation lesions

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* Significant, \>50% diameter stenosis artery scheduled for intervention of the main vessel (Medina types: 1x1, x11, 111); * Side branch vessel at least 2.0 mm

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University National Heart Hospital: lead

Study Sites (1)

Alexandrovska University Hospital

Sofia, Bulgaria

RECRUITING

Related Publications (1)

• Vassilev DI, Mileva NB, Yaneva-Sirakova T, Georgiev RS, Kassab G. Validation of Coronary Wire for the Acquisition of Intracoronary Electrocardiogram in Swine. Catheter Cardiovasc Interv. 2025 Nov;106(5):3030-3033. doi: 10.1002/ccd.70145. Epub 2025 Sep 7.

  PMID: 40916341 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Dobrin Vassilev

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dobrin Vassilev

CONTACT

+359886846550; dobrinv@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 19, 2019
• Study Start: February 1, 2019
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2024
• Last Updated: August 19, 2019

Record last verified: 2019-08

Locations

BU (1)