Registry of Secondary Revascularization

NCT03349385 | Active Not Recruiting

• 1 other identifier: ROV-EPI-2017-01
• Study Type: observational
• Target: 869
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease Progression; Coronary Artery Disease of Significant Bypass Graft; Stent Stenosis; Stent Restenosis; Coronary Arteriosclerosis

Keywords

Secondary revascularization; Repeat revascularization; Coronary revascularization; Coronary artery bypass graft

Outcome Measures

Primary Outcomes (1)

• Patient-oriented composite endpoint

  Composite endpoint including: all-cause death, any myocardial infarction or any new unplanned revascularization

  1 year

Secondary Outcomes (5)

• Rates of individual components of primary outcome

  1 to 5 years

• Composite endpoint at 2 to 5 years

  2 to 5 years

• Rate of failure of previous revascularization

  baseline (assessed at index catheterization)

• Recurrent angina (CCS class, patients reported)

  1 to 5 years

• Feasibility of secondary revascularization

  per protocol, 1 month after index catheterization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead
• Laboratorios Farmacéuticos Rovi, S.A.: collaborator
• S&H MEDICAL SCIENCE SERVICE, S.L.: collaborator

Study Sites (1)

Hospital Clinico San Carlos

Madrid, Madrid, 28005, Spain

Location

Related Publications (2)

• Salinas P, Vilchez-Tschischke JP, Noriega F, Macaya F, Rosillo S, Garcia-Camarero T, de la Torre-Hernandez JM, de Tapia B, Jimenez-Kockar M, Regueiro A, Flores-Umanzor E, Garcia-Blas S, Gonzalez-D'Gregorio J, Gomez-Menchero AE, Diaz-Fernandez JF, Rondan J, Amat-Santos I, Ojeda S, Diez-Gil JL, de Miguel Castro A, Lozano Ruiz-Poveda F, Fernandez-Diaz JA, Manzano MC, Cruz-Gonzalez I, Pascual Tejerina V, Garcia Perez-Velasco J, Serra A, Poveda-Andres JL, Macaya C, Escaned J. Design and Rationale for a Real-World Prospective, Multicenter Registry of Myocardial Revascularization Failure and Secondary Revascularization: The REVASEC Study. Cardiovasc Revasc Med. 2022 Jul;40:50-56. doi: 10.1016/j.carrev.2021.11.015. Epub 2021 Nov 16.

  PMID: 34857473 BACKGROUND

• Salinas P, Garcia-Camarero T, Jimenez-Kockar M, Regueiro A, Garcia-Blas S, Gomez-Menchero AE, Ojeda S, Vilchez-Tschischke JP, Amat-Santos I, Diez-Gil JL, Rondan J, Lozano Ruiz-Poveda F, de Miguel Castro A, Manzano MC, Pascual-Tejerina V, Cruz-Gonzalez I, Garcia Perez-Velasco J, Fernandez-Diaz JA, Escaned J; REVASEC working group (collaborators). Myocardial revascularization failure among patients requiring cardiac catheterization and secondary revascularization in contemporary clinical practice: Results of the REVASEC multicenter registry. Catheter Cardiovasc Interv. 2023 Oct;102(4):608-619. doi: 10.1002/ccd.30804. Epub 2023 Aug 15.

  PMID: 37582340 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Pablo Salinas, MD, PhD

  Hospital San Carlos, Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 11, 2017
• First Posted: November 21, 2017
• Study Start: November 22, 2017
• Primary Completion: May 31, 2021
• Study Completion: December 15, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)