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

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ClinicalTrials.gov Identifier: NCT04060615
Recruitment Status : Active, not recruiting
First Posted : August 19, 2019
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
Clinical Centre of Serbia
Information provided by (Responsible Party):
Milan Dobric, University of Belgrade

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

Condition or disease Intervention/treatment Phase
Chronic Total Occlusion of Coronary Artery Procedure: percutaneous coronary intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All patients with chronic total occlusion will undergo the PCI procedure of the occlusion.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Properties of Myocardial Microcirculation in Patients With Different Pathomorphological Substrates, Before and After Recanalization of Coronary Artery Chronic Total Occlusion
Actual Study Start Date : March 28, 2017
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : January 15, 2020

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04060615


Locations
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Serbia
Clinical Centre of Serbia, University of Belgrade
Belgrade, Serbia, 11000
Sponsors and Collaborators
University of Belgrade
Clinical Centre of Serbia
Investigators
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Study Director: Branko D Beleslin, MD, PhD University of Belgrade
Study Director: Miodrag C Ostojic, MD, PhD University of Belgrade
  Study Documents (Full-Text)

Documents provided by Milan Dobric, University of Belgrade:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Milan Dobric, Assistant professor, University of Belgrade
ClinicalTrials.gov Identifier: NCT04060615    
Other Study ID Numbers: 61206-1296/2-17
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Milan Dobric, University of Belgrade:
chronic total occlusion
coronary flow reserve