Pharmacologic Treatment of Myocardial Ischemia Detected by Intracoronary ECG

NCT03383393 | Unknown DMC

• 1 other identifier: Alexandrovska UH
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Ischemia

Outcome Measures

Primary Outcomes (1)

• Intracoronary ischemia change after intracoronary drug bolus

  Look for ischemia change after intracoronary drugs

  12 months

Secondary Outcomes (4)

• Target lesion revascularization

  12 months

• Number of patients not alive

  12 months

• Myocardial infarction

  12 months

• New onset angina or heart failure symptoms

  12 months

Study Arms (3)

adenosine

Intracoronary bolus of adenosine (adenocor)

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

GP IIb/IIIa

Intracoronary bolus of Integrilin (eptifibatide)

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

Nitroglycerine

Intracoronary bolus of nitroglycerine (nitronal)

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

Interventions

Intracoronary bolus of adenosine (adenocor), Integrilin (eptifibatide) or nitroglyzerin (nitronal) DRUG

intracoronary drugs

GP IIb/IIIa; Nitroglycerine; adenosine

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients that go under percutaneous interventions

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandrovska University Hospital: lead

Study Sites (1)

Alexandrovska University Hospital

Sofia, 1413, Bulgaria

RECRUITING

MeSH Terms

Interventions

Eptifibatide

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, Principal Investigator

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 26, 2017
• Study Start: January 3, 2018
• Primary Completion: December 5, 2019
• Study Completion: December 5, 2019
• Last Updated: December 26, 2017

Record last verified: 2017-12

Locations

BU (1)