Protocol for The Lipid Registry of Africa

Acute Coronary Syndrome Clinical Trial

Official title:

Protocol for The Lipid Registry of Africa (LIPRA)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06238375
• Other study ID #: 3000124
• Status: Not yet recruiting
• Start date: April 30, 2024
• Est. completion date: December 30, 2026

Study information

• Verified date: February 2024
• Source: European Atherosclerosis Society
• Contact: Ashraf Reda, MD
• Phone: 01002122902
• Email: ashrafreda5555[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4000
• Est. completion date: December 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Atherosclerosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
European Atherosclerosis Society

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk factors prevalence	The prevalence of traditional Cardiovascular (CV) risk factors among African patients with premature Acute Coronary Syndrome (ACS).	Through study completion, an average of 1 year
Secondary	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.	Through study completion, an average of 1 year
Secondary	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.	Through study completion, an average of 1 year
Secondary	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.	Through study completion, an average of 1 year