Properties of Myocardial Microcirculation in Patients With Different Pathomorphological Substrates, Before and After Recanalization of Coronary Artery CTO

September 24, 2019 updated by: Milan Dobric, University of Belgrade

Properties of Myocardial Microcirculation in Patients With Different Pathomorphological Substrates, Before and After Recanalization of Coronary Artery Chronic Total Occlusion

This study will evaluate the changes in myocardial microcirculatory parameters of the collateral donor artery after recanalization of coronary artery chronic total occlusion.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Centre of Serbia, University of Belgrade

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Procedure: percutaneous coronary intervention
PCI of the chronic total occlusion of the coronary artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coronary flow reserve
Time Frame: six months
Change in coronary flow reserve of the collateral donor vessel (after PCI as compared to values before PCI) will be regarded as primary outcome measure
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coronary flow velocity reserve
Time Frame: six months
Correlation of coronary flow velocity reserve change of the collateral donor vessel (after PCI as compared to values before PCI) with viability measured by the percentage of viable myocardium on Single Photon Emission Computed Tomography (SPECT) of myocardial perfusion.
six months
Wall Motion Score Index (WMSI)
Time Frame: six months
Relation of coronary flow velocity reserve change with wall motion score index on stres-echocardyography test where the wall motion segment abnormalities will be graded as such: 1 - normokinesis, 2 - hypokinesis, 3- akinesis and 4 dyskinesis, and the higher values indicates worse outcome
six months
Change from Baseline Stable Angina questionnaire (SAQ) at 6 months
Time Frame: six months
Relation of coronary flow velocity reserve change with the quality of life measured by 19-item Seattle Angina Questionnaire that assesses angina frequency (with 9 questions where answers range from 1 to 6, the total score ranges from 0 to 100, where the higher value indicates better outcome), angina stability ( with 1 question where answers range from 1 to 6, the total score ranges from 0 to 100, where the higher value indicates better outcome), the angina frequency scale (with 2 questions where answers range from 1 to 5, the total score ranges from 0 to 100, where the higher value indicates better outcome), treatment satisfaction (with 4 questions where answers range from 1 to 6, the total score ranges from 0 to 100, where the higher value indicates better outcome), and disease perception/QoL (with 3 questions where answers range from 1 to 5, the total score ranges from 0 to 100, where the higher value indicates better outcome)
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Belgrade

Collaborators

Clinical Centre of Serbia

Investigators

  • Study Director: Branko D Beleslin, MD, PhD, University of Belgrade
  • Study Director: Miodrag C Ostojic, MD, PhD, University of Belgrade

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2017

Primary Completion (Anticipated)

December 15, 2019

Study Completion (Anticipated)

January 15, 2020

Study Registration Dates

First Submitted

August 4, 2019

First Submitted That Met QC Criteria

August 14, 2019

First Posted (Actual)

August 19, 2019

Study Record Updates

Last Update Posted (Actual)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 61206-1296/2-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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