Properties of Myocardial Microcirculation in Patients With Different Pathomorphological Substrates, Before and After Recanalization of Coronary Artery CTO
NCT ID: NCT04060615
Last Updated: 2019-09-25
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
30 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-03-28
Study Completion Date
2020-01-15
Brief Summary
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This study will evaluate the changes in myocardial microcirculatory parameters of the collateral donor artery after recanalization of coronary artery chronic total occlusion.
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Detailed Description
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This study will include patients with chronic total occlusion (CTO) of one coronary artery who will undergo the recanalization of the CTO. Before the procedure, myocardial viability, ischemia, functional parameters of the collateral donor blood vessels, echocardiography, and quality of life will be assessed. After the recanalization, these parameters will be assessed again 24h and 6 months after the procedure.
Conditions
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Chronic Total Occlusion of Coronary Artery
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
All patients with chronic total occlusion will undergo the PCI procedure of the occlusion.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Patients with chronic total occlusion of the coronary artery
In each patient before the PCI procedure, the investigators will assess myocardial viability, functional parameters of collateral blood vessels, and quality of life. 24h and 6 months after the procedure these parameters will be reevaluated as well as functional parameters of the treated coronary artery.
Group Type
OTHER
percutaneous coronary intervention
Intervention Type
PROCEDURE
PCI of the chronic total occlusion of the coronary artery
Interventions
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percutaneous coronary intervention
PCI of the chronic total occlusion of the coronary artery
Intervention Type
PROCEDURE
Eligibility Criteria
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Inclusion Criteria
* Patients over the age of 18 with signed informed consent to participate in the study
* Presence of one CTO on native coronary arteries (with TIMI 0 flow)
* Presence of clinical indication for attempting a PCI for CTO (at least one of the criteria present):
1. Symptoms of typical stable angina
2. Presence of inducible ischemia in the territory of the occluded artery
3. Presence of viable myocardium in the territory of the occluded artery
* The diameter of the occluded artery ≥2.5mm
* Presence of one CTO on native coronary arteries (with TIMI 0 flow)
* Presence of clinical indication for attempting a PCI for CTO (at least one of the criteria present):
1. Symptoms of typical stable angina
2. Presence of inducible ischemia in the territory of the occluded artery
3. Presence of viable myocardium in the territory of the occluded artery
* The diameter of the occluded artery ≥2.5mm
Exclusion Criteria
* Acute coronary syndrome in the past month
* Existing contraindication for administration of dual antiplatelet therapy in the duration of 12 months
* Contraindications for implanting the drug-eluting stents
* Existence of 2 or more CTOs on native coronary arteries (with TIMI 0 flow)
* Severe tortuosity or calcifications of the coronary arteries
* Left ventricle aneurysm
* Previous coronary artery bay-pass graft or any other cardiac surgery
* Previous myocardial infarction in the coronary artery territory different from the CTO
* Ejection fraction of the left ventricle less than 30%
* Permanent atrial fibrillation
* Pregnancy
* Patients with known allergy to iodine contrast that cannot be controlled with medication
* Patients who are unable or unwilling to cooperate and come for check-up visits
* Life expectancy less than a year
* Hemorrhagic diathesis, coagulopathy, or rejection of blood transfusion
* Existing contraindication for administration of dual antiplatelet therapy in the duration of 12 months
* Contraindications for implanting the drug-eluting stents
* Existence of 2 or more CTOs on native coronary arteries (with TIMI 0 flow)
* Severe tortuosity or calcifications of the coronary arteries
* Left ventricle aneurysm
* Previous coronary artery bay-pass graft or any other cardiac surgery
* Previous myocardial infarction in the coronary artery territory different from the CTO
* Ejection fraction of the left ventricle less than 30%
* Permanent atrial fibrillation
* Pregnancy
* Patients with known allergy to iodine contrast that cannot be controlled with medication
* Patients who are unable or unwilling to cooperate and come for check-up visits
* Life expectancy less than a year
* Hemorrhagic diathesis, coagulopathy, or rejection of blood transfusion
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Clinical Centre of Serbia
OTHER
Sponsor Role
collaborator
University of Belgrade
OTHER
Sponsor Role
lead
Responsible Party
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Milan Dobric
Assistant professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Branko D Beleslin, MD, PhD
Role: STUDY_DIRECTOR
University of Belgrade
Miodrag C Ostojic, MD, PhD
Role: STUDY_DIRECTOR
University of Belgrade
Locations
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Clinical Centre of Serbia, University of Belgrade
Belgrade, , Serbia
Site Status
Countries
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Serbia
References
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DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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61206-1296/2-17
Identifier Type: -
Identifier Source: org_study_id
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