Registry of Secondary Revascularization (REVASEC)

November 9, 2023 updated by: Pablo Salinas, Hospital San Carlos, Madrid

Multicenter Registry of Secondary Revascularization

The study will evaluate patients with, at least, one previous procedure of coronary revascularization (surgical, percutaneous or both), that are referred for a new, clinically indicated, diagnostic coronary angiography, to describe their clinical characteristics, management, and prognosis, and will propose a prognosis-oriented classification.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Secondary or repeated revascularization refers to any repeated coronary intervention following an index coronary revascularization procedure, and represents a wide proportion of patients received in catheterization laboratories. These patients have an increased complexity and worse outcomes than patients without previous revascularization. Clinical investigation has focused in lesion-specific treatments when a single previous revascularization fails, but there is paucity of patient-level information including complex patients with multiple revascularizations. Other gaps in evidence addressed by this study are the absence of a a prognosis-oriented classification of previously revascularized patients and a clinical meaningful definition of revascularization failure. The registry as well intends to provide insights on how secondary revascularization decisions are taken and long term prognosis after secondary revascularization.

The registry of secondary revascularization (in Spanish: Registro multicéntrico de reVAscularización SECundaria, REVASEC) is a multicenter, prospective, observational cohort study that incudes consecutive patients with at least one previous coronary revascularization undergoing a clinically indicated diagnostic coronary angiography, in different Spanish hospitals. The aims are describing the incidence, clinical profile, therapeutic management and prognosis of these patients.

Study Type

Observational

Enrollment (Actual)

869

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
      • Madrid, Spain, 28005
        • Hospital Clínico San Carlos

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

Sampling Method

Non-Probability Sample

Study Population

Patients with at least one previous coronary revascularization undergoing a clinically indicated diagnostic coronary angiography

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Previous successful coronary revascularization, either percutaneous or surgical, in at least one vessel with diameter ≥2 mm
  • Previous successful coronary revascularization must have been successful in at least one vessel and the patient must have been discharged after the previous revascularization
  • Clinically indicated diagnostic coronary angiography
  • Provide written informed consent

Exclusion Criteria:

  • Inability or refusal to provide written informed consent
  • Patient included in any other clinical trial in which the revascularization device is blind to patient or investigator, or is not commercially available
  • Insufficient data about previous revascularizations
  • Previous revascularization only on vessels of less than 2 mm or which was not successful in any vessel
  • Previous percutaneous revascularization with simple plain old balloon angioplasty
  • Index coronary angiography indicated as scheduled repeated angiography, planned percutaneous coronary intervention, or pre-surgical angiography

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-oriented composite endpoint
Time Frame: 1 year
Composite endpoint including: all-cause death, any myocardial infarction or any new unplanned revascularization
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of individual components of primary outcome
Time Frame: 1 to 5 years
Rates of individual components of primary outcomes: all-cause death, myocardial infarction or new unplanned revascularization
1 to 5 years
Composite endpoint at 2 to 5 years
Time Frame: 2 to 5 years
Composite endpoint including: all-cause death, any myocardial infarction or new unplanned revascularization
2 to 5 years
Rate of failure of previous revascularization
Time Frame: baseline (assessed at index catheterization)
Rate of failure of previous revascularization using the classical definition: >50% stent restenosis or >50% stenosis in a surgical graft
baseline (assessed at index catheterization)
Recurrent angina (CCS class, patients reported)
Time Frame: 1 to 5 years
Describe the presence of recurrent angina (CCS class) and analyze its predictors
1 to 5 years
Feasibility of secondary revascularization
Time Frame: per protocol, 1 month after index catheterization
Define the rates of successful and complete revascularization
per protocol, 1 month after index catheterization

Collaborators and Investigators

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

Sponsor

Hospital San Carlos, Madrid

Collaborators

Laboratorios Farmacéuticos Rovi, S.A.
S&H MEDICAL SCIENCE SERVICE, S.L.

Investigators

  • Principal Investigator: Pablo Salinas, MD, PhD, Hospital San Carlos, Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 22, 2017

Primary Completion (Actual)

May 31, 2021

Study Completion (Estimated)

January 15, 2025

Study Registration Dates

First Submitted

November 11, 2017

First Submitted That Met QC Criteria

November 19, 2017

First Posted (Actual)

November 21, 2017

Study Record Updates

Last Update Posted (Estimated)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 9, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROV-EPI-2017-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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