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

March 2, 2022 updated by: Parc de Salut Mar

Evolución de Las Resistencias Microvasculares y Del Flujo Coronario Absoluto en Pacientes Con intervención Coronaria percutánea de Una oclusión crónica

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain
        • Hospital Universitari de Bellvitge
      • Cadiz, Spain
        • Hospital Puerta del Mar
      • Madrid, Spain
        • Hospital Universitario de La Princesa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with ischemic heart disease and evidence of at least one chronic total occlusion, with data of inducible ischemia and/or viability and susceptible to percutaneous coronary intervention.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Global cohort

Invasive coronary physiology parameters estimation, including:

FFR, CFR, IMR, Absolute coronary flow (AF). AF derived resistances
Diagnostic test: Invasive coronary physiology
Estimation of guide-wire coronary physiology parameters
Other Names:
  • fractional flow reserve
  • coronary flow reserve
  • index of microvascular resistance
  • absolute coronary flow
  • AF-derived coronary resistance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Variation in the values of IMR between basal and 6-months follow-up
Time Frame: 6 months
6 months
Variation in the values of absolute coronary flow between basal and 6-months follow-up
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2020

Primary Completion (ANTICIPATED)

September 30, 2022

Study Completion (ANTICIPATED)

September 30, 2022

Study Registration Dates

First Submitted

January 5, 2022

First Submitted That Met QC Criteria

January 5, 2022

First Posted (ACTUAL)

January 19, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 3, 2022

Last Update Submitted That Met QC Criteria

March 2, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLOW1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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