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

NCT ID: NCT05197361

Last Updated: 2022-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-09-30

Brief Summary

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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

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Conditions

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Chronic Total Occlusion of Coronary Artery Microvascular Coronary Artery Disease Coronary; Ischemic Coronary Microvascular Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Global cohort

Invasive coronary physiology parameters estimation, including:

FFR, CFR, IMR, Absolute coronary flow (AF). AF derived resistances

Invasive coronary physiology

Intervention Type DIAGNOSTIC_TEST

Estimation of guide-wire coronary physiology parameters

Interventions

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Invasive coronary physiology

Estimation of guide-wire coronary physiology parameters

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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fractional flow reserve coronary flow reserve index of microvascular resistance absolute coronary flow AF-derived coronary resistance

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Parc de Salut Mar

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital del Mar

Barcelona, , Spain

Site Status

Hospital Universitari de Bellvitge

Barcelona, , Spain

Site Status

Hospital Puerta del Mar

Cadiz, , Spain

Site Status

Hospital Universitario de La Princesa

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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FLOW1

Identifier Type: -

Identifier Source: org_study_id

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