Ischaemic Heart DiseaseMICENCT04061525
Motion and IntraCoronary Ecg Ischemia Development Study (MICE)
An observational study of Ischaemic Heart Disease, run by University National Heart Hospital at 1 site in Bulgaria.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ischaemic Heart Disease
- What is being tested?
- Percutaneous coronary intervention with FFR measurement and intracoronary ECG registration
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteBulgaria
- Study dates
- 1 Feb 2019to Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site, 1 recruiting
- Recruiting
Alexandrovska University Hospital
Sofia
Dobrin Vassilev, +359886846550, dobrinv@gmail.com
About this study
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.
Read the 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
- Being tested
- Percutaneous coronary intervention with FFR measurement and intracoronary ECG registration
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary intervention with FFR measurement and intracoronary ECG registrationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Procedure: Percutaneous coronary intervention with FFR measurement and intracoronary ECG registration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side branch region ischemia
Beginning, duration, sequence of the electric, kinetic and haemodynamic signs of ischemia, comparison between ischemic cascade and constellation.
Measured: Percutaneous coronary intervention procedure time (up to 4 hours)
Secondary outcomes (4)
Target lesion revascularization
Any revascularization at the territory of previously intervention
Measured: 12 months
Number of patients not alive
Number of patients not alive
Measured: 12 months
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
Measured: 12 months
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start1 Feb 2019
- Primary completionJan 2022 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischaemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University National Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dobrin Vassilev, Alexandrovska University Hospital
- Investigators
- Dobrin Vassilev, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061525
- Sponsor's protocol ID
- MICE-102019
- Acronym
- MICE
- Status last verified
- Aug 2019
- First submitted
- 15 Aug 2019
- Last updated
- 19 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40916341
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motion and IntraCoronary Ecg Ischemia Development Study (MICE)
- ClinicalTrials.gov ID
- NCT04061525
- Acronym / sponsor ID
- MICE / MICE-102019
- Conditions
- Ischaemic Heart Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University National Heart HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 19 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with coronary bifurcation lesions | – | Procedure: Percutaneous coronary intervention with FFR measurement and intracoronary ECG registrationPatients 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) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous coronary intervention with FFR measurement and intracoronary ECG registrationMeasurement 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. | Procedure or surgery | Patients with coronary bifurcation lesions |
Primary outcome
Side branch region ischemia
Time frame: Percutaneous coronary intervention procedure time (up to 4 hours)
Beginning, duration, sequence of the electric, kinetic and haemodynamic signs of ischemia, comparison between ischemic cascade and constellation.
4 secondary outcomes
Target lesion revascularization
Time frame: 12 months
Number of patients not alive
Time frame: 12 months
Myocardial infarction after hospital discharge
Time frame: 12 months
New onset angina or heart failure symptoms
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- Derived from this study: PubMed 40916341Vassilev 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dobrin Vassilev principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischaemic Heart Disease, run by University National Heart Hospital at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dobrin Vassilev (+359886846550, dobrinv@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side branch region ischemia (time frame: Percutaneous coronary intervention procedure time (up to 4 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04061525, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2019; AzTrials last refreshed its copy on 1 Nov 2026.