Clinical trial NCT04060615: Properties of Myocardial Microcirculation in Patients With Different Pathomorphological Substrates, Before and After Recanalization of Coronary Artery CTO
Official title: Properties of Myocardial Microcirculation in Patients With Different Pathomorphological Substrates, Before and After Recanalization of Coronary Artery Chronic Total Occlusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Total Occlusion of Coronary Artery
Keywords: chronic total occlusion
coronary flow reserve
Lead sponsor: University of Belgrade
Sponsor class: OTHER
Collaborators: name: Clinical Centre of Serbia
First posted: 2019-08-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients with chronic total occlusion will undergo the PCI procedure of the occlusion.
Primary purpose: TREATMENT

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.

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):

  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

Primary outcomes:
measure: Coronary flow reserve
timeFrame: six months
Secondary outcomes:
measure: Coronary flow velocity reserve
timeFrame: six months
measure: Wall Motion Score Index (WMSI)
timeFrame: six months
measure: Change from Baseline Stable Angina questionnaire (SAQ) at 6 months
timeFrame: six months
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Clinical Centre of Serbia, University of Belgrade
Study officials:
affiliation: University of Belgrade
name: Branko D Beleslin, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Belgrade
name: Miodrag C Ostojic, MD, PhD
role: STUDY_DIRECTOR
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