Role of LipoprotEin(a) in CardiovascuLar Diseases and Premature Acute Coronary Syndromes - (RELACS) Study

NCT05496790 | Unknown

• 1 other identifier: CECN/1385
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Coronary Syndrome; Lipoprotein Disorder; Acute Myocardial Infarction; Cardiovascular Diseases

Keywords

Lipoprotein(a); Lp(a); Acute Coronary Syndrome (ACS); Acute Myocardial Infarction; Premature ACS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Each component of the primary enpoint

  Through study completion, an average of 1 year

• Lp(a) levels in premature ACS

  Through study completion, an average of 1 year

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18-60 years with documented coronary artery disease

You may qualify if:

• 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:
• at least one CV event before 60 years of age;
• multiple CV events despite optimal medical therapy.
• Signature of informed consent.

You may not qualify if:

• Age \> 60 years
• Patients experiencing cardiogenic shock and unable to provide informed consent.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

AORN S. Anna e S. Sebastiano

Caserta, 81100, Italy

RECRUITING

Related Publications (2)

• 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, Calabro 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.

  PMID: 32858625 BACKGROUND

• Gragnano F, Fimiani F, Di Maio M, Cesaro A, Limongelli G, Cattano D, Calabro 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. No abstract available.

  PMID: 30929131 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases

Central Study Contacts

Arturo Cesaro, MD

CONTACT

0823232543; arturo.cesaro@unicampania.it

Fabio Fimiani, BSc

CONTACT

0823232395; fimianifabio@hotmail.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 11, 2022
• Study Start: January 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: December 1, 2024
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)