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

NCT ID: NCT07197242

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 156 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-10-01
• Study Completion Date: 2027-12-30

Brief Summary

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.

Conditions

PCI

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Adult patients (≥18 years old) undergoing elective PCI for stable coronary artery disease will form

The targeted cohort consists of men and women presenting with stable ischemic heart disease scheduled to undergo elective PCI at the Assiut University Heart Hospital cardiac catheterization unit

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

ahmed gamal abdelhakeem ahmed

resident at Cardiology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 37754581 (View on PubMed)

Other Identifiers

Lp(a) and Risk in Elective PCI

Identifier Type: -

Identifier Source: org_study_id