Clinical trial NCT03383393: Pharmacologic Treatment of Myocardial Ischemia Detected by Intracoronary ECG
Official title: Pharmacologic Treatment of Myocardial Ischemia Detected by Intracoronary ECG
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Ischemia
Lead sponsor: Alexandrovska University Hospital
Sponsor class: OTHER
First posted: 2017-12-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients that go under percutaneous interventions

Brief summary: After PCI searching for target lesion ischemia with intracoronary ECG will be performed and if found it will be treated pharmacologically

Detailed description: The study will include patients with coronary lesions and PCI. It will include patients with stable or unstable angina, without elevated hs-TnT. PCI will be performed and monitoring of intracoronary ST elevation. Any dissection or acute vessel closure will be promptly treated with balloon or stenting.

Although there could be good angiographic result sometimes ischemia could be detected in the treated region by means of intracoronary ECG ST elevation above 1mm.

This study aims to tackle this issue with randomization of the patients into three possible treatments - intracoronary adenosine, IIb/IIIa inhibitors or nitroglycerine alone - intracoronary ST segment will be searched for reverse or residual ischemia after the pharmacologic bolus.

The intracoronary electrocardiography (i.c. ECG) is a very sensitive method for ischemia detection. The i.c. ECG reacts earlier on ischemia; the changes are much more prominent and easy to register. The wire tip could be positioned directly in different regions and thus to "map" regional ischemia. In most of the studies and from our own observations became evident that when surface ECG do not react the i.c. ECG demonstrates significant changes in ST-segment and QRS complex. Moreover, the registration of i.c. ECG is very cheap and needs only an adapter connecting coronary wire end and ECG. An i.c. ECG also can differentiate residual ischemic changes in distal main vessel and side branch as sources of prolonged ischemia, respectively - source of periprocedural myonecrosis.

Once good angiographic result is obtained after stenting there could be different reasons for ischemia in the treated region - microembolic debris or coronary microvascular spasm.

Eligibility criteria: Inclusion Criteria:

* Subject at least 18 years of age.
* Target lesion(s) located in a native coronary artery with diameter of ≥ 2.5 mm and ≤ 4.5 mm. If there is 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 target lesion, 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.

Primary outcomes:
measure: Intracoronary ischemia change after intracoronary drug bolus
timeFrame: 12 months
Secondary outcomes:
measure: Target lesion revascularization
timeFrame: 12 months
measure: Number of patients not alive
timeFrame: 12 months
measure: Myocardial infarction
timeFrame: 12 months
measure: New onset angina or heart failure symptoms
timeFrame: 12 months
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Alexandrovska University Hospital
Study officials:
References: