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Acute Coronary SyndromeRELACSNCT05496790

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

An observational study of Acute Coronary Syndrome and Lipoprotein Disorder, run by University of Campania Luigi Vanvitelli at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
How many people
1,000 participants
Where
1 siteItaly
Study dates
1 Jan 2021to Dec 2024
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: Patients aged 18-60 years with documented coronary artery disease

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Arturo Cesaro, MD contact

0823232543

arturo.cesaro@unicampania.it

Fabio Fimiani, BSc contact

0823232395

fimianifabio@hotmail.it

Italy1 site, 1 recruiting

  • AORN S. Anna e S. Sebastiano

    Caserta, 81100

    Arturo Cesaro, MD, 0823232543, arturo.cesaro@unicampania.it

    Fabio Fimiani, BSc, 0823232395, fimianifabio@hotmail.it

    Recruiting

Other trials in Italy

About this study

Official title: Role of Lipoprotein(a) in Patients With Cardiovascular Diseases and Young Patients With Premature Acute Coronary Syndromes

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.

Read the detailed description

Although acute myocardial infarction (AMI) is more common in the elderly, its incidence in young patients is increasing. The exact pathogenetic mechanism of AMI in young patients remains largely unknown and involves the interaction of multiple genetic and environmental factors related to atherothrombosis. The cardiovascular risk profile and coronary artery disease burden differ between young and elderly patients with AMI. Generally, compared with elderly patients, patients with premature AMI have a lower atherosclerotic burden, as well as a lower incidence of hypertension and diabetes mellitus. Still, they more frequently have a hypercoagulable state with high fibrinogen and D-dimer levels and genetic disorders of lipid metabolism (1) with elevated triglyceride and lipoprotein (a) [Lp(a)] levels (2).

Lp(a) is a lipoprotein with pro-atherogenic, pro-thrombotic and pro-inflammatory properties (3). Lp(a) consists of a lipid component with apoB100 and a protein component represented by Apo(a)(3,4). Apo(a) shows substantial structural homology with plasminogen, suggesting that the former protein can inhibit the binding of plasminogen to its receptor, thereby interfering with fibrinolysis and inducing a prothrombotic state. Several studies have shown that increased plasma levels of Lp(a) are associated with an increased risk of coronary artery disease (5), peripheral arteriopathy (6), cerebrovascular disease (7), abdominal aortic aneurysm, aortic valve stenosis and calcification (8), and venous thromboembolism (9). In addition, elevated Lp(a) levels are associated with an increased risk of major cardiac adverse events (10). In contrast, a recent study that included approximately 1,500 patients with a history of acute coronary syndrome (ACS) at least six months after enrollment showed that Lp(a) appears to be an independent risk factor for ACS in individuals <45 years young (especially in the presence of LDL-C cholesterol levels >70 mg/dL) (11). This association is of lesser magnitude (but still preserved) between 45-60 years of age and becomes nonsignificant after 60 years of age. Despite increasing evidence in the literature, Lp(a) determination is infrequently performed in patients with early-onset ACS referred to Cardiology Departments and Outpatient Departments. Therefore, hyper-Lp(a) remains largely under-diagnosed even in patients at high or very high cardiovascular risk.

Therefore, the purpose of our study is to evaluate the correlation between Lp(a) and recurrence of cardiovascular events such as cardiovascular mortality, recurrence of anginal symptoms, new revascularizations (PCI/CABG), or new hospitalizations at 1-year follow-up in patients with premature ACS, which includes myocardial infarction with ST-segment elevation (STEMI), acute myocardial infarction without ST-segment elevation (NSTEMI) and unstable angina (UA).

Keywords
Lipoprotein(a), Lp(a), Acute Coronary Syndrome (ACS), Acute Myocardial Infarction, Premature ACS
Medical subject headings
Acute Coronary Syndrome, Cardiovascular Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Through study completion, an average of 1 year

Secondary outcomes (2)

  1. 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.

    Measured: Through study completion, an average of 1 year

  2. Lp(a) levels in premature ACS

    To assess Lp(a) levels in subjects with early-onset acute coronary syndrome

    Measured: Through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2022
  2. Study start1 Jan 2021
  3. Primary completion30 Sep 2022 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05496790
Sponsor's protocol ID
CECN/1385
Acronym
RELACS
Status last verified
Aug 2022
First submitted
9 Aug 2022
Last updated
11 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32858625

  • 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.

    PubMed 30929131

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Coronary Syndrome and Lipoprotein Disorder, run by University of Campania Luigi Vanvitelli at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Arturo Cesaro, MD (0823232543, arturo.cesaro@unicampania.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Impact of Lp(a) on MACE (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05496790, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.

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