Lp(A)GAELpaNCT06297239
Argentine Registry of Lp(a)
An observational study of Lp(A) and Hypercholesterolemia, run by School of Medicine. National University of Cuyo at 1 site in Argentina.
Trial summary
The Argentine Registry on Lipoprotein(a) (LP(a)), orchestrated by the Argentine Group for LP(a) Study, stands as a pioneering and extensive prospective initiative. This registry systematically collects geolocation data, including patient postal codes, demographic information, and a multifaceted array of health… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lp(A), Hypercholesterolemia, Cardiovascular Diseases
- How many people
- 1,000 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Feb 2024to 1 Feb 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Adult patients residing in Argentina
Inclusion Criteria: Adult patients with validated Lp(a) values -
Exclusion Criteria: Associated pathologies that can increase the Lp(a) value in a non-specific manner
-
Trial locations and contacts
1 site in 1 country.
Pablo Corral, MD contact
Argentina1 site, 1 recruiting
- Recruiting
Universidad Nacional de Cuyo
Mendoza, 5500
Nicolás F Renna, PhD MD FESC, +5492615714415, nicolasfede@gmail.com
Pablo Corral, MD
About this study
Official title: Argentine Registry for the Study of Lipoprotein a
The Argentine Registry on Lipoprotein(a) (LP(a)), orchestrated by the Argentine Group for LP(a) Study, stands as a pioneering and extensive prospective initiative. This registry systematically collects geolocation data, including patient postal codes, demographic information, and a multifaceted array of health parameters to unravel the intricate associations surrounding LP(a) levels.
The dataset encompasses diverse patient characteristics, ranging from standard metrics like blood pressure, weight, and race to broader factors such as diabetes, smoking habits, menopausal status, and hypothyroidism. This holistic approach enables a nuanced exploration of the interplay between LP(a) levels and various risk factors, providing invaluable insights for both clinical and public health considerations.
Read more
One distinctive feature of this registry lies in its focus on medication history, shedding light on the impact of routine pharmaceutical interventions on LP(a) profiles. Additionally, it delves into the intricate web of inflammatory diseases, recognizing their potential role in LP(a) modulation.
Genetic predispositions are meticulously examined, with a specific emphasis on identifying homozygous and heterozygous variants associated with hypercholesterolemia. This genetic dimension adds a layer of complexity to the understanding of LP(a) dynamics, contributing significantly to the ongoing discourse on cardiovascular risk.
The prospective nature of this registry allows for dynamic analyses, fostering a continuous exploration of emerging patterns and trends. By amalgamating geographical, clinical, and genetic data, the Argentine LP(a) Registry emerges as a comprehensive platform poised to unlock novel facets of LP(a) biology and its implications for cardiovascular health. As the dataset matures, it holds the promise of guiding personalized interventions and refining risk stratification strategies, thereby advancing the landscape of preventive cardiovascular care.
- Keywords
- LP(a), Cardiovascular risk
- Medical subject headings
- Hypercholesterolemia, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of high level of Lp(a)
prevalence of high level of Lp(a)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start1 Feb 2024
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lp(A)Studies of the same condition, open and under way.
- 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
- 1,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- School of Medicine. National University of Cuyo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pablo Corral, MD, Study chair, FASTA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297239
- Sponsor's protocol ID
- UC001
- Acronym
- GAELpa
- Status last verified
- Feb 2024
- First submitted
- 27 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Argentine Registry for the Study of Lipoprotein a
- ClinicalTrials.gov ID
- NCT06297239
- Acronym / sponsor ID
- GAELpa / UC001
- Keywords
- LP(a), Cardiovascular risk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- School of Medicine. National University of CuyoUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 7 Mar 2024 (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 Argentine Registry on Lipoprotein(a) (LP(a)), orchestrated by the Argentine Group for LP(a) Study, stands as a pioneering and extensive prospective initiative. This registry systematically collects geolocation data, including patient postal codes, demographic information, and a multifaceted array of health parameters to unravel the intricate associations surrounding LP(a) levels.
The dataset encompasses diverse patient characteristics, ranging from standard metrics like blood pressure, weight, and race to broader factors such as diabetes, smoking habits, menopausal status, and hypothyroidism. This holistic approach enables a nuanced exploration of the interplay between LP(a) levels and various risk factors, providing invaluable insights for both clinical and public health considerations.
One distinctive feature of this registry lies in its focus on medication history, shedding light on the impact of routine pharmaceutical interventions on LP(a) profiles. Additionally, it delves into the intricate web of inflammatory diseases, recognizing their potential role in LP(a) modulation.
Genetic predispositions are meticulously examined, with a specific emphasis on identifying homozygous and heterozygous variants associated with hypercholesterolemia. This genetic dimension adds a layer of complexity to the understanding of LP(a) dynamics, contributing significantly to the ongoing discourse on cardiovascular risk.
The prospective nature of this registry allows for dynamic analyses, fostering a continuous exploration of emerging patterns and trends. By amalgamating geographical, clinical, and genetic data, the Argentine LP(a) Registry emerges as a comprehensive platform poised to unlock novel facets of LP(a) biology and its implications for cardiovascular health. As the dataset matures, it holds the promise of guiding personalized interventions and refining risk stratification strategies, thereby advancing the landscape of preventive cardiovascular care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients residing in Argentina
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
prevalence of high level of Lp(a)
Time frame: 2 years
prevalence of high level of Lp(a)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
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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. This study is not recruiting at the moment.
Pablo Corral, MD contact
Pablo Corral, MD study chair
FASTA University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lp(A) and Hypercholesterolemia, run by School of Medicine. National University of Cuyo at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolás F Renna, MD PhD FESC (+5492615714415, nicolasfede@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of high level of Lp(a) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2024.