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

University of Belgrade

Status: Unknown

Conditions: Chronic Total Occlusion of Coronary Artery

Treatments: Procedure: percutaneous coronary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04060615

61206-1296/2-17

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Patients with chronic total occlusion of the coronary artery

Other group

Description:

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.

Treatment:

Procedure: percutaneous coronary intervention