Acute Coronary SyndromeNCT06238375
Protocol for The Lipid Registry of Africa
An observational study of Acute Coronary Syndrome and Atherosclerosis, run by European Atherosclerosis Society.
Trial summary
The Lipid Registry of Africa (LIPRA) aims to understand why some individuals in Africa experience heart issues at a younger age than others. The study investigates factors causing heart problems in younger adults, particularly acute coronary syndrome (ACS). Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Acute Coronary Syndrome, Atherosclerosis
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2024to 30 Dec 2026
- 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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The Lipid Registry of Africa (LIPRA) focuses on individuals residing in Africa (Urban and rural) diagnosed with premature Acute Coronary Syndrome (ACS). This encompasses patients admitted to specialized cardiac facilities in these regions meeting stringent criteria for ACS subtypes-ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction/unstable angina pectoris (NSTEMI/UAP). Inclusion mandates symptoms, electrocardiogram (ECG) alterations, and biomarker levels consistent with Acute Coronary Syndrome (ACS) within the specified age range (≤55 years in men, ≤65 years in women). The study aims to scrutinize the risk factor profile and demographics, uncovering the prevalence and impact of established and emerging risk factors for coronary artery disease. LIPRA, a multinational initiative, collaborates across diverse healthcare facilities, pooling data from multiple African countries.
Who may be able to join
- Individuals diagnosed with premature Acute Coronary Syndrome (ACS) within the defined age range (≤55 years in men and ≤65 years in women).
- Patients admitted to designated cardiac facilities in Africa (Urban and rural).
- Diagnosed cases of ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction/unstable angina pectoris (NSTEMI/UAP) based on predetermined criteria including symptoms, electrocardiogram (ECG) alterations, and biomarker levels.
- Patients exhibiting an increase (above the 95th percentile) or decrease in serum troponin levels as per admission standards.
Who cannot join
- Individuals outside the defined age range for premature Acute Coronary Syndrome (ACS) diagnosis.
- Patients not admitted to designated cardiac facilities in Africa.
- Diagnosed cases not meeting the specified criteria for Acute Coronary Syndrome (ACS) subtypes (STEMI, NSTEMI/UAP) based on symptoms, electrocardiogram (ECG), and biomarker levels.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Protocol for The Lipid Registry of Africa (LIPRA)
The Lipid Registry of Africa (LIPRA) aims to understand why some individuals in Africa experience heart issues at a younger age than others. The study investigates factors causing heart problems in younger adults, particularly acute coronary syndrome (ACS). Acute coronary syndrome (ACS) includes various heart conditions like unstable angina and heart attacks. Researchers from multiple African countries collaborate to gather information from hospitals across the region. They focus on patients under 55 years (men) or 65 years (women) with heart issues.
Additionally, the study wants to compare different groups-men and women, urban and rural residents-to see if there are specific differences in how heart problems develop among them.
- Conditions
- Acute Coronary Syndrome, Atherosclerosis
- Keywords
- Lipid Registry of Africa, Acute Coronary Syndrome, Cardiovascular Risk Factors, Multinational Study
- Medical subject headings
- Acute Coronary Syndrome, Atherosclerosis
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 |
|---|---|---|
| Premature Acute Coronary Syndrome (ACS) Patients in Africa | This cohort includes individuals diagnosed with premature Acute Coronary Syndrome (ACS), including subtypes like unstable angina, non-ST-segment elevation myocardial infarction (NSTEMI), and myocardial infarction with persistent ST-segment elevation (STEMI). These participants are under 55 years (men) or 65 years (women) and have been admitted to various cardiac facilities in Africa (Urban and rural) due to ACS-related symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors prevalence
The prevalence of traditional Cardiovascular (CV) risk factors among African patients with premature Acute Coronary Syndrome (ACS).
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
Gender Difference in Risk Factors
This secondary outcome aims to assess and compare the risk factor profiles between male and female individuals diagnosed with premature acute coronary syndrome (ACS) in Africa.
Measured: Through study completion, an average of 1 year
Prevalence of Familial Hypercholesterolemia (FH) According to the Dutch Lipid Clinic Network Score (DLCNS)
This secondary outcome aims to determine the prevalence of Familial Hypercholesterolemia (FH) within the study population using the Dutch Lipid Clinic Network Score (DLCNS).
The DLCNS is a diagnostic tool used to estimate the likelihood of FH based on a combination of genetic, clinical, and family history criteria. It assigns points across various categories, and the total score categorizes the probability of FH as "Definite," "Probable," "Possible," or "Unlikely." Minimum and Maximum Values: The DLCNS has a scoring system that ranges from 0 to >8 points. The minimum score (0 points) would typically indicate a lower likelihood of FH, while the maximum (>8 points) suggests a definite FH diagnosis.
Measured: Through study completion, an average of 1 year
Prevalence of the Use of Invasive Strategy Compared to Conservative Strategy for Managing Patients with Acute Coronary Syndrome (ACS) in Africa
This secondary outcome aims to investigate the prevalence of the use of invasive strategy (e.g., coronary angiography and revascularization) compared to conservative strategy (medical management without immediate invasive procedures) for managing patients diagnosed with acute coronary syndrome (ACS) in Africa.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start30 Apr 2024 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Atherosclerosis Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashraf Reda, MD, Principal investigator, The Egyptian Association of Vascular biology and Atherosclerosis (EAVA)Alexandros D. Tselepis, MD, PhD, Principal investigator, Biochemistry-Clinical Chemistry, Chemistry Department, University of Ioannina, GreeceAlberto Zambon, MD, PhD, Principal investigator, Department of Medicine -University of Padua School of Medicine - ItalyAlexander R.M. Lyons, PhD, Principal investigator, Imperial College, London, Faculty of Medicine, School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238375
- Sponsor's protocol ID
- 3000124
- Status last verified
- Feb 2024
- First submitted
- 24 Jan 2024
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol will be made available upon a reasonable request to the director of the project
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for The Lipid Registry of Africa (LIPRA)
- ClinicalTrials.gov ID
- NCT06238375
- Acronym / sponsor ID
- 3000124
- Conditions
- Acute Coronary Syndrome, Atherosclerosis
- Keywords
- Lipid Registry of Africa, Acute Coronary Syndrome, Cardiovascular Risk Factors, Multinational Study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- European Atherosclerosis SocietyUniversity, hospital or other
- Study start
- 30 Apr 2024 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 2 Feb 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 Lipid Registry of Africa (LIPRA) aims to understand why some individuals in Africa experience heart issues at a younger age than others. The study investigates factors causing heart problems in younger adults, particularly acute coronary syndrome (ACS). Acute coronary syndrome (ACS) includes various heart conditions like unstable angina and heart attacks. Researchers from multiple African countries collaborate to gather information from hospitals across the region. They focus on patients under 55 years (men) or 65 years (women) with heart issues.
Additionally, the study wants to compare different groups-men and women, urban and rural residents-to see if there are specific differences in how heart problems develop among them.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Premature Acute Coronary Syndrome (ACS) Patients in Africa | – | –This cohort includes individuals diagnosed with premature Acute Coronary Syndrome (ACS), including subtypes like unstable angina, non-ST-segment elevation myocardial infarction (NSTEMI), and myocardial infarction with persistent ST-segment elevation (STEMI). These participants are under 55 years (men) or 65 years (women) and have been admitted to various cardiac facilities in Africa (Urban and rural) due to ACS-related symptoms. |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The Lipid Registry of Africa (LIPRA) focuses on individuals residing in Africa (Urban and rural) diagnosed with premature Acute Coronary Syndrome (ACS). This encompasses patients admitted to specialized cardiac facilities in these regions meeting stringent criteria for ACS subtypes-ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction/unstable angina pectoris (NSTEMI/UAP). Inclusion mandates symptoms, electrocardiogram (ECG) alterations, and biomarker levels consistent with Acute Coronary Syndrome (ACS) within the specified age range (≤55 years in men, ≤65 years in women). The study aims to scrutinize the risk factor profile and demographics, uncovering the prevalence and impact of established and emerging risk factors for coronary artery disease. LIPRA, a multinational initiative, collaborates across diverse healthcare facilities, pooling data from multiple African countries.
Key inclusion criteria (4 listed)
- Individuals diagnosed with premature Acute Coronary Syndrome (ACS) within the defined age range (≤55 years in men and ≤65 years in women).
- Patients admitted to designated cardiac facilities in Africa (Urban and rural).
- Diagnosed cases of ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction/unstable angina pectoris (NSTEMI/UAP) based on predetermined criteria including symptoms, electrocardiogram (ECG) alterations, and biomarker levels.
- Patients exhibiting an increase (above the 95th percentile) or decrease in serum troponin levels as per admission standards.
Key exclusion criteria (3 listed)
- Individuals outside the defined age range for premature Acute Coronary Syndrome (ACS) diagnosis.
- Patients not admitted to designated cardiac facilities in Africa.
- Diagnosed cases not meeting the specified criteria for Acute Coronary Syndrome (ACS) subtypes (STEMI, NSTEMI/UAP) based on symptoms, electrocardiogram (ECG), and biomarker levels.
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
Risk factors prevalence
Time frame: Through study completion, an average of 1 year
The prevalence of traditional Cardiovascular (CV) risk factors among African patients with premature Acute Coronary Syndrome (ACS).
3 secondary outcomes
Gender Difference in Risk Factors
Time frame: Through study completion, an average of 1 year
Prevalence of Familial Hypercholesterolemia (FH) According to the Dutch Lipid Clinic Network Score (DLCNS)
Time frame: Through study completion, an average of 1 year
Prevalence of the Use of Invasive Strategy Compared to Conservative Strategy for Managing Patients with Acute Coronary Syndrome (ACS) in Africa
Time frame: Through study completion, an average of 1 year
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 2 Feb 2024.
- Individual participant dataSharing planned: Yes. The study protocol will be made available upon a reasonable request to the director of the project
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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.
Ashraf Reda, MD principal investigator
The Egyptian Association of Vascular biology and Atherosclerosis (EAVA)
Alexandros D. Tselepis, MD, PhD principal investigator
Biochemistry-Clinical Chemistry, Chemistry Department, University of Ioannina, Greece
Alberto Zambon, MD, PhD principal investigator
Department of Medicine -University of Padua School of Medicine - Italy
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Atherosclerosis, run by European Atherosclerosis Society.
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 3 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 2 Feb 2024. 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?
Contact Ashraf Reda, MD (01002122902 ext. +2, ashrafreda5555@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk factors prevalence (time frame: Through study completion, an average of 1 year). 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 2 Feb 2024.