Clinical trial NCT03349385: Registry of Secondary Revascularization
Official title: Multicenter Registry of Secondary Revascularization
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
Collaborators: name: Laboratorios Farmacéuticos Rovi, S.A.
name: S&H MEDICAL SCIENCE SERVICE, S.L.
First posted: 2017-11-21
Enrollment: 869
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with at least one previous coronary revascularization undergoing a clinically indicated diagnostic coronary angiography

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient-oriented composite endpoint
timeFrame: 1 year
Secondary outcomes:
measure: Rates of individual components of primary outcome
timeFrame: 1 to 5 years
measure: Composite endpoint at 2 to 5 years
timeFrame: 2 to 5 years
measure: Rate of failure of previous revascularization
timeFrame: baseline (assessed at index catheterization)
measure: Recurrent angina (CCS class, patients reported)
timeFrame: 1 to 5 years
measure: Feasibility of secondary revascularization
timeFrame: per protocol, 1 month after index catheterization
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
Study officials:
affiliation: Hospital San Carlos, Madrid
name: Pablo Salinas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.