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Pharmacologic Treatment of Myocardial Ischemia Detected by Intracoronary ECG

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ClinicalTrials.gov Identifier: NCT03383393
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : December 26, 2017
Sponsor:
Information provided by (Responsible Party):
Lyubomir Dosev, Alexandrovska University Hospital

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

Condition or disease Intervention/treatment
Coronary Ischemia 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Pharmacologic Treatment of Myocardial Ischemia Detected by Intracoronary ECG
Estimated Study Start Date : January 3, 2018
Estimated Primary Completion Date : December 5, 2019
Estimated Study Completion Date : December 5, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Intracoronary ischemia change after intracoronary drug bolus [ Time Frame: 12 months ]
    Look for ischemia change after intracoronary drugs


Secondary Outcome Measures :
  1. Target lesion revascularization [ Time Frame: 12 months ]
    Any revascularization at the territory of previously implanted stent.

  2. Number of patients not alive [ Time Frame: 12 months ]
    death

  3. Myocardial infarction [ Time Frame: 12 months ]
    MI after discharge

  4. 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



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients that go under percutaneous interventions
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383393


Locations
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Bulgaria
Alexandrovska University Hospital Recruiting
Sofia, Bulgaria, 1413
Contact: Liubomir Dosev, MD    +359887493695    liubodosev@gmail.com   
Sponsors and Collaborators
Alexandrovska University Hospital

Additional Information:

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Responsible Party: Lyubomir Dosev, Doctor, Principal Investigator, Alexandrovska University Hospital
ClinicalTrials.gov Identifier: NCT03383393     History of Changes
Other Study ID Numbers: Alexandrovska UH
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Myocardial Ischemia
Coronary Artery Disease
Ischemia
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Adenosine
Nitroglycerin
Eptifibatide
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors