NCT07209631

Brief Summary

This work aimed to evaluate the association of serum level of Lp(a) with the severity of coronary artery disease (CAD) in aortic valve sclerosis (AVS) patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 7, 2025

Completed
Last Updated

October 7, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

September 29, 2025

Last Update Submit

September 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of significance of coronary lesions

    Incidence of significance of coronary lesions in relation to lipoprotein (a) level was recorded.

    1 month post-procedure

Study Arms (1)

Study group

Patients with chest pain and/or dyspnea were diagnosed provisionally as having coronary artery disease.

Other: Serum Lipoprotein-a level

Interventions

A venous blood sample was taken from each patient a month or so after discharge to check their Lp (a) levels. The samples were centrifuged for 10 minutes at 2-8 °C, after which the serum was divided into aliquots and stored at -20 ° C.

Study group

Eligibility Criteria

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

This prospective cohort study was carried out on 100 patients. The study was done after approval from the local Ethics Committee (Under the Declaration of Helsinki). Informed written consent was obtained from the patients.

You may qualify if:

  • Age ≥ 18 years.
  • Both sexes.
  • Patients with chest pain and/or dyspnea were diagnosed provisionally as having coronary artery disease.

You may not qualify if:

  • Aortic stenosis.
  • Aortic prosthesis.
  • Untreated hypothyroidism.
  • Severe chronic kidney failure.
  • Administration of anti-inflammatory or immunosuppressive drugs.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, 82511, Egypt

Location

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
Lecturer of Cardiovascular, Faculty of Medicine, Sohag University, Sohag, Egypt.

Study Record Dates

First Submitted

September 29, 2025

First Posted

October 7, 2025

Study Start

October 1, 2024

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

October 7, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations