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

Not Applicable

• Conditions: Chronic Total Occlusion of Coronary Artery
• Interventions: Procedure: percutaneous coronary intervention

• Registration Number: NCT04060615
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-03-28
• Study First Submitted: 2019-08-04
• Study First Submitted QC: 2019-08-14
• Study First Posted: 2019-08-19
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-25
• Primary Completion: 2019-12-15
• Study Completion: 2020-01-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with chronic total occlusion of the coronary artery	percutaneous coronary intervention	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.

Primary Outcome Measures

Name	Time	Method
Coronary flow reserve	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

Name	Time	Method
Coronary flow velocity reserve	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.
Wall Motion Score Index (WMSI)	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
Change from Baseline Stable Angina questionnaire (SAQ) at 6 months	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)

Trial Locations

Locations (1)

Clinical Centre of Serbia, University of Belgrade; 🇷🇸 Belgrade, Serbia