Pharmacologic Treatment of Myocardial Ischemia Detected by Intracoronary ECG

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

Study Overview

• Status: Unknown
• Conditions: Coronary Ischemia
• Intervention / Treatment: Drug: Intracoronary bolus of adenosine (adenocor), Integrilin (eptifibatide) or nitroglyzerin (nitronal)

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1413
    • Recruiting
    • Alexandrovska University Hospital
    • Contact: Liubomir Dosev, MD; Phone Number: +359887493695; Email: liubodosev@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients that go under percutaneous interventions

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
adenosine; Intracoronary bolus of adenosine (adenocor)	Drug: Intracoronary bolus of adenosine (adenocor), Integrilin (eptifibatide) or nitroglyzerin (nitronal); intracoronary drugs
GP IIb/IIIa; Intracoronary bolus of Integrilin (eptifibatide)	Drug: Intracoronary bolus of adenosine (adenocor), Integrilin (eptifibatide) or nitroglyzerin (nitronal); intracoronary drugs
Nitroglycerine; Intracoronary bolus of nitroglycerine (nitronal)	Drug: Intracoronary bolus of adenosine (adenocor), Integrilin (eptifibatide) or nitroglyzerin (nitronal); intracoronary drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intracoronary ischemia change after intracoronary drug bolus	Look for ischemia change after intracoronary drugs	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target lesion revascularization	Any revascularization at the territory of previously implanted stent.	12 months
Number of patients not alive	death	12 months
Myocardial infarction	MI after discharge	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	12 months

Collaborators and Investigators

• Sponsor: Alexandrovska University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 3, 2018
• Primary Completion (Anticipated): December 5, 2019
• Study Completion (Anticipated): December 5, 2019

Study Registration Dates

• First Submitted: December 4, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 26, 2017

Study Record Updates

• Last Update Posted (Actual): December 26, 2017
• Last Update Submitted That Met QC Criteria: December 19, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Ischemia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Platelet Aggregation Inhibitors; Purinergic Agents; Purinergic P1 Receptor Agonists; Purinergic Agonists; Adenosine; Eptifibatide
• Other Study ID Numbers: Alexandrovska UH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No