Pharmacologic Treatment of Myocardial Ischemia Detected by Intracoronary ECG

Coronary Ischemia Clinical Trial

Official title:

Pharmacologic Treatment of Myocardial Ischemia Detected by Intracoronary ECG

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03383393
• Other study ID #: Alexandrovska UH
• Status: Recruiting
• Phase: N/A
• First received: December 4, 2017
• Last updated: December 19, 2017
• Start date: January 3, 2018
• Est. completion date: December 5, 2019

Study information

• Verified date: December 2017
• Source: Alexandrovska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 5, 2019
• Est. primary completion date: December 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Ischemia
• Ischemia
• Myocardial Ischemia

Intervention

Drug:
• Intracoronary bolus of adenosine (adenocor), Integrilin (eptifibatide) or nitroglyzerin (nitronal)
intracoronary drugs

Locations

Country	Name	City	State
Bulgaria	Alexandrovska University Hospital	Sofia

Sponsors (1)

Lead Sponsor	Collaborator
Alexandrovska University Hospital

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracoronary ischemia change after intracoronary drug bolus	Look for ischemia change after intracoronary drugs	12 months
Secondary	Target lesion revascularization	Any revascularization at the territory of previously implanted stent.	12 months
Secondary	Number of patients not alive	death	12 months
Secondary	Myocardial infarction	MI after discharge	12 months
Secondary	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	12 months