Protocol for The Lipid Registry of Africa

NCT06238375 | Not Yet Recruiting DMC

• 1 other identifier: 3000124
• Study Type: observational
• Target: 4,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Coronary Syndrome; Atherosclerosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Gender Difference in Risk Factors

  Through study completion, an average of 1 year

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

  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

  Through study completion, an average of 1 year

Study Arms (1)

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.

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• European Atherosclerosis Society: lead

MeSH Terms

Conditions

Acute Coronary Syndrome; Atherosclerosis

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Ashraf Reda, MD

  The Egyptian Association of Vascular biology and Atherosclerosis (EAVA)

  PRINCIPAL INVESTIGATOR

• Alexandros D. Tselepis, MD, PhD

  Biochemistry-Clinical Chemistry, Chemistry Department, University of Ioannina, Greece

  PRINCIPAL INVESTIGATOR

• Alberto Zambon, MD, PhD

  Department of Medicine -University of Padua School of Medicine - Italy

  PRINCIPAL INVESTIGATOR

• Alexander R.M. Lyons, PhD

  Imperial College, London, Faculty of Medicine, School of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashraf Reda, MD

CONTACT

01002122902; ashrafreda5555@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 2, 2024
• Study Start: April 30, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year after the end of the study.