An observational study in Coronary Artery Disease Progression, Coronary Artery Disease of Significant Bypass Graft and Stent Stenosis, sponsored by Hospital San Carlos, Madrid. Active, not recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-24.
Sponsored by Hospital San Carlos, Madrid · Observational
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.
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.
Patients with at least one previous coronary revascularization undergoing a clinically indicated diagnostic coronary angiography
Exclusion Criteria:
Patient-oriented composite endpoint
Composite endpoint including: all-cause death, any myocardial infarction or any new unplanned revascularization
Time frame: 1 year
Rates of individual components of primary outcome
Rates of individual components of primary outcomes: all-cause death, myocardial infarction or new unplanned revascularization
Time frame: 1 to 5 years
Composite endpoint at 2 to 5 years
Composite endpoint including: all-cause death, any myocardial infarction or new unplanned revascularization
Time frame: 2 to 5 years
Rate of failure of previous revascularization
Rate of failure of previous revascularization using the classical definition: \>50% stent restenosis or \>50% stenosis in a surgical graft
Time frame: baseline (assessed at index catheterization)
Recurrent angina (CCS class, patients reported)
Describe the presence of recurrent angina (CCS class) and analyze its predictors
Time frame: 1 to 5 years
Feasibility of secondary revascularization
Define the rates of successful and complete revascularization
Time frame: per protocol, 1 month after index catheterization
Plan to share: No
This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Hospital San Carlos, Madrid