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Not yet recruiting NCT07197242

Prognostic Role of Lipoprotein(a) in Elective Percutaneous Coronary Revascularization

Observational PCI

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: PCI. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Assessment of Lipoprotein(a) in Patients Undergoing Elective Percutaneous Coronary Revascularization: Implications for Cardiovascular Risk Stratification

Overview

The study investigates the role of Lipoprotein(a) \[Lp(a)\] levels in predicting cardiovascular risk and adverse events in patients undergoing elective percutaneous coronary intervention (PCI).

Detailed description

his is a multicenter prospective observational cohort study conducted at Assiut University Heart Hospital and affiliated centers. The study focuses on patients undergoing elective (non-ACS) PCI for stable coronary artery disease. Baseline Lp(a) levels will be measured pre-PCI using isoform-insensitive immunoassays, and patients will be followed for 24 months to document cardiovascular outcomes. The primary goal is to assess whether elevated Lp(a) (≥125 nmol/L) independently predicts 2-year major adverse cardiovascular events (MACE) beyond conventional risk factors and procedural complexity. The study also aims to evaluate the prevalence of elevated Lp(a) among this population and its incremental prognostic value for refining risk stratification models such as SYNTAX II/ACEF. Collected blood samples will be stored in a biobank for future exploratory analyses.

Primary outcome measures

  • Incidence of major adverse cardiovascular events (MACE) [Time frame: one year]

Eligibility criteria

Inclusion criteria

  • Adults aged 18 years or older

Undergoing elective PCI for stable coronary artery disease

Ability to provide informed consent

Willingness to undergo blood sampling prior to PCI

Exclusion criteria

  • Acute coronary syndrome within 30 days

Cardiogenic shock

Prior heart transplant or left ventricular assist device (LVAD)

Life expectancy less than 1 year due to non-cardiac causes

Participation in a blinded Lp(a)-lowering outcome trial at the time of enrollment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Vinci P, Di Girolamo FG, Panizon E, Tosoni LM, Cerrato C, Pellicori F, Altamura N, Pirulli A, Zaccari M, Biasinutto C, Roni C, Fiotti N, Schincariol P, Mangogna A, Biolo G. Lipoprotein(a) as a Risk Factor for Cardiovascular Diseases: Pathophysiology and Treatment Perspectives. Int J Environ Res Public Health. 2023 Sep 6;20(18):6721. doi: 10.3390/ijerph20186721. PMID 37754581

Identifiers

NCT: NCT07197242 · Lp(a) and Risk in Elective PCI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗