Protocol for The Lipid Registry of Africa

Protocol for The Lipid Registry of Africa (LIPRA)

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06238375

Enrollment

4000

Registered

2024-02-02

Start date

2024-04-30

Completion date

2026-12-30

Last updated

2024-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Atherosclerosis

Keywords

Lipid Registry of Africa, Acute Coronary Syndrome, Cardiovascular Risk Factors, Multinational Study

Brief 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). 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Risk factors prevalence	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

Measure	Time frame	Description
Gender Difference in Risk Factors	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)	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	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.

Contacts

Primary ContactAshraf Reda, MD

ashrafreda5555@gmail.com01002122902

Outcome results