Microvascular Coronary Resistance and Absolute Coronary FLOW in Patients With Percutaneous Intervention of a Chronic Total Occlusion

• Conditions: Microvascular Coronary Artery Disease; Coronary Microvascular Dysfunction; Chronic Total Occlusion of Coronary Artery; Coronary; Ischemic
• Interventions: Diagnostic Test: Invasive coronary physiology

• Registration Number: NCT05197361
• Lead Sponsor: Parc de Salut Mar

Brief Summary

It is an observational study which objective is to analyze, through a series of invasive parameters, the state of the coronary microvasculature immediately after the successful percutaneous coronary intervention of a chronic total occlusion and at 6 months after the index procedure.

The aim of the study is to check the variation in the values of the index of microcirculatory resistance (IMR) and invasive absolute coronary flow (AF). The working hypothesis is that, in the follow-up of these patients, AF will increase significantly with respect to its baseline and, conversely, IMR will be reduced during the follow-up.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-01-05
• Study First Posted: 2022-01-19
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-02
• Last Update Posted: 2022-03-03
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Those patients with a clinical indication for percutaneous coronary intervention of a chronic total occlusion. As a routine clinical practice in our center, it is proposed to perform a angiographic follow-up 6 months after the index procedure.

Exclusion Criteria

• No specific exclusion criteria.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Global cohort	Invasive coronary physiology	Invasive coronary physiology parameters estimation, including: FFR, CFR, IMR, Absolute coronary flow (AF). AF derived resistances

Primary Outcome Measures

Name	Time	Method
Variation in the values of IMR between basal and 6-months follow-up	6 months
Variation in the values of absolute coronary flow between basal and 6-months follow-up	6 months

Trial Locations

Locations (4)

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital Universitari de Bellvitge; 🇪🇸 Barcelona, Spain

Hospital Puerta del Mar; 🇪🇸 Cadiz, Spain

Hospital Universitario de La Princesa; 🇪🇸 Madrid, Spain