Clinical trial NCT06238375: Protocol for The Lipid Registry of Africa
Official title: Protocol for The Lipid Registry of Africa (LIPRA)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Coronary Syndrome
Atherosclerosis
Keywords: Lipid Registry of Africa
Acute Coronary Syndrome
Cardiovascular Risk Factors
Multinational Study
Lead sponsor: European Atherosclerosis Society
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 4000
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Risk factors prevalence
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Gender Difference in Risk Factors
timeFrame: Through study completion, an average of 1 year
measure: Prevalence of Familial Hypercholesterolemia (FH) According to the Dutch Lipid Clinic Network Score (DLCNS)
timeFrame: Through study completion, an average of 1 year
measure: Prevalence of the Use of Invasive Strategy Compared to Conservative Strategy for Managing Patients with Acute Coronary Syndrome (ACS) in Africa
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
affiliation: The Egyptian Association of Vascular biology and Atherosclerosis (EAVA)
name: Ashraf Reda, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Biochemistry-Clinical Chemistry, Chemistry Department, University of Ioannina, Greece
name: Alexandros D. Tselepis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Medicine -University of Padua School of Medicine - Italy
name: Alberto Zambon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College, London, Faculty of Medicine, School of Public Health
name: Alexander R.M. Lyons, PhD
role: PRINCIPAL_INVESTIGATOR
References: