Cardiovascular Diseases Clinical Trial
— RELACSOfficial title:
Role of Lipoprotein(a) in Patients With Cardiovascular Diseases and Young Patients With Premature Acute Coronary Syndromes
NCT number | NCT05496790 |
Other study ID # | CECN/1385 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2021 |
Est. completion date | December 2024 |
Several clinical and preclinical studies have focused interest on lipoprotein(a) [Lp(a)], showing a direct and independent relationship of its circulating levels with the progression of atherosclerosis and its clinical manifestations. However, to date, Lp(a) represents an underestimated predictor of CV risk, especially in higher-risk populations, such as patients with strong CV familiarity and recurrent and/or early-onset CV events. The key point of the project will be the evaluation of the role of Lp(a) in the development of atherosclerotic disease and, specifically, acute coronary syndrome.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | December 2024 |
Est. primary completion date | September 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Age >18 years - Documented coronary artery disease (i.e.,acute coronary syndrome [ACS], percutaneous coronary intervention [PCI], coronary artery bypass graft surgery [CABG], and at least one of the following: 1. at least one CV event before 60 years of age; 2. multiple CV events despite optimal medical therapy. - Signature of informed consent. Exclusion Criteria: - Age > 60 years - Patients experiencing cardiogenic shock and unable to provide informed consent. |
Country | Name | City | State |
---|---|---|---|
Italy | AORN S. Anna e S. Sebastiano | Caserta |
Lead Sponsor | Collaborator |
---|---|
University of Campania "Luigi Vanvitelli" |
Italy,
Cesaro A, Schiavo A, Moscarella E, Coletta S, Conte M, Gragnano F, Fimiani F, Monda E, Caiazza M, Limongelli G, D'Erasmo L, Riccio C, Arca M, Calabrò P. Lipoprotein(a): a genetic marker for cardiovascular disease and target for emerging therapies. J Cardiovasc Med (Hagerstown). 2021 Mar 1;22(3):151-161. doi: 10.2459/JCM.0000000000001077. Review. — View Citation
Gragnano F, Fimiani F, Di Maio M, Cesaro A, Limongelli G, Cattano D, Calabrò P. Impact of lipoprotein(a) levels on recurrent cardiovascular events in patients with premature coronary artery disease. Intern Emerg Med. 2019 Jun;14(4):621-625. doi: 10.1007/s11739-019-02082-8. Epub 2019 Mar 30. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Impact of Lp(a) on MACE | Assess at a 1-year follow-up, the impact of Lp(a) on the major cardiovascular events (MACE) defined as cardiovascular mortality, recurrence of anginal symptoms, new revascularizations (PCI/CABG), stroke, or new hospitalizations for cardiovascular causes. | Through study completion, an average of 1 year | |
Secondary | Each component of the primary enpoint | To assess the incidence of cardiovascular events individually such as cardiovascular mortality, recurrence of anginal symptoms, new revascularizations (PCI/CABG), stroke, or new hospitalizations for cardiovascular causes at 1-year follow-up, in patients with elevated Lp(a) levels. | Through study completion, an average of 1 year | |
Secondary | Lp(a) levels in premature ACS | To assess Lp(a) levels in subjects with early-onset acute coronary syndrome | Through study completion, an average of 1 year |
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