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

NCT04060615 | Unknown

• 1 other identifier: 61206-1296/2-17
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Total Occlusion of Coronary Artery

Keywords

chronic total occlusion; coronary flow reserve

Outcome Measures

Primary Outcomes (1)

• Coronary flow reserve

  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 Outcomes (3)

• Coronary flow velocity reserve

  six months

• Wall Motion Score Index (WMSI)

  six months

• Change from Baseline Stable Angina questionnaire (SAQ) at 6 months

  six months

Study Arms (1)

Patients with chronic total occlusion of the coronary artery

OTHER

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

Interventions

percutaneous coronary intervention PROCEDURE

PCI of the chronic total occlusion of the coronary artery

Patients with chronic total occlusion of the coronary artery

Eligibility Criteria

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

You may qualify if:

• 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):
• Symptoms of typical stable angina
• Presence of inducible ischemia in the territory of the occluded artery
• Presence of viable myocardium in the territory of the occluded artery
• The diameter of the occluded artery ≥2.5mm

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Belgrade: lead
• Clinical Centre of Serbia: collaborator

Study Sites (1)

Clinical Centre of Serbia, University of Belgrade

Belgrade, 11000, Serbia

Location

Related Publications (42)

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MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Branko D Beleslin, MD, PhD

  University of Belgrade

  STUDY DIRECTOR

• Miodrag C Ostojic, MD, PhD

  University of Belgrade

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: All patients with chronic total occlusion will undergo the PCI procedure of the occlusion.

Study Record Dates

• First Submitted: August 4, 2019
• First Posted: August 19, 2019
• Study Start: March 28, 2017
• Primary Completion: December 15, 2019
• Study Completion: January 15, 2020
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)