NCT07197242

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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
15mo left

Started Oct 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 29, 2025

Completed
1 year until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

9 months

First QC Date

September 20, 2025

Last Update Submit

September 20, 2025

Conditions

Keywords

PCIcoronary artery disease

Outcome Measures

Primary Outcomes (1)

  • Incidence of major adverse cardiovascular events (MACE)

    Incidence of all non-fatal myocardial infarction, and ischemia-driven target vessel revascularization or or definite/probable stent thrombosis.

    one year

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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. Eligible patients must provide informed consent and undergo baseline blood sampling. The study excludes patients with recent acute coronary syndrome (ACS within 30 days), cardiogenic shock, prior cardiac transplantation/LVAD, limited life expectancy from non-cardiac causes, or those enrolled in contemporary blinded clinical trials specifically for Lp(a)-lowering therapies. By selecting an elective CAD population, the study narrows focus to a lower baseline

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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: 37754581BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident at Cardiology Department

Study Record Dates

First Submitted

September 20, 2025

First Posted

September 29, 2025

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share