PCINCT07197242
Prognostic Role of Lipoprotein(a) in Elective Percutaneous Coronary Revascularization
An observational study of PCI, run by Assiut University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PCI
- How many people
- 156 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Assessment of Lipoprotein(a) in Patients Undergoing Elective Percutaneous Coronary Revascularization: Implications for Cardiovascular Risk Stratification
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).
Read the 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
- Keywords
- PCI, coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Oct 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PCIStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed gamal abdelhakeem ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197242
- Sponsor's protocol ID
- Lp(a) and Risk in Elective PCI
- Status last verified
- Sep 2025
- First submitted
- 20 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37754581
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Lipoprotein(a) in Patients Undergoing Elective Percutaneous Coronary Revascularization: Implications for Cardiovascular Risk Stratification
- ClinicalTrials.gov ID
- NCT07197242
- Acronym / sponsor ID
- Lp(a) and Risk in Elective PCI
- Conditions
- PCI
- Keywords
- PCI, coronary artery disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of major adverse cardiovascular events (MACE)
Time frame: one year
Incidence of all non-fatal myocardial infarction, and ischemia-driven target vessel revascularization or or definite/probable stent thrombosis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Background: PubMed 37754581Vinci 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of PCI, run by Assiut University.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of major adverse cardiovascular events (MACE) (time frame: one 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 NCT07197242, which also lists 1 linked publication.
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 29 Sep 2025.