Protocol for The Lipid Registry of Africa

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.

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Key information

Conditions

Acute Coronary Syndrome Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

Up to 65 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

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).

Secondary outcomes

Gender Difference in Risk Factors

Time frame: Through study completion, an average of 1 year

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.
Prevalence of Familial Hypercholesterolemia (FH) According to the Dutch Lipid Clinic Network Score (DLCNS)

Time frame: Through study completion, an average of 1 year

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.
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

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ashraf Reda, MD

CONTACT

[email protected]

01002122902 ext. +2

Sponsors and collaborators

Lead sponsor

European Atherosclerosis Society

Other

Registry information

Official study title

Protocol for The Lipid Registry of Africa (LIPRA)

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Feb 2, 2024
Registry last updated: Feb 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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