DRUG
Intracoronary bolus of adenosine (adenocor), Integrilin (eptifibatide) or nitroglyzerin (nitronal)
intracoronary drugs
Status
Unknown
Phase
Not applicable
Enrollment
60
Locations
1
Results
Not posted
Publications
0
Study summary
After PCI searching for target lesion ischemia with intracoronary ECG will be performed and if found it will be treated pharmacologically
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.
Interventions
DRUG
intracoronary drugs
Timeline
First posted
Dec 26, 2017
Study start
Jan 3, 2018
Primary completion
Dec 5, 2019
Study completion
Dec 5, 2019
Results posted
Not reported
Registry updated
Dec 26, 2017
Outcomes
Intracoronary ischemia change after intracoronary drug bolus
Time frame · 12 months
Look for ischemia change after intracoronary drugs
Target lesion revascularization
Time frame · 12 months
Any revascularization at the territory of previously implanted stent.
Number of patients not alive
Time frame · 12 months
death
Myocardial infarction
Time frame · 12 months
MI after discharge
New onset angina or heart failure symptoms
Time frame · 12 months
New onset angina symptoms of at least CCS class II; New onset dyspnea at exertion or at rest
Eligibility
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.
Study locations
Bulgaria. Showing up to 24 locations stored in the fast local snapshot.
Alexandrovska University Hospital
Sofia, Bulgaria
Publications
No PMID-linked publications were present in this registry snapshot.
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