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Clinical Trials/NCT04060615
NCT04060615
Unknown
N/A

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

University of Belgrade1 site in 1 country30 target enrollmentMarch 28, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Total Occlusion of Coronary Artery
Sponsor
University of Belgrade
Enrollment
30
Locations
1
Primary Endpoint
Coronary flow reserve
Last Updated
6 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
March 28, 2017
End Date
January 15, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Milan Dobric

Assistant professor

University of Belgrade

Eligibility 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):
  • 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

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

Outcomes

Primary Outcomes

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 Outcomes

  • 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 Sites (1)

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