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AHC-BHS: AHC Ballana Heart Study

Sponsor
Magdi Yacoub Heart Foundation (Other)
Overall Status
Recruiting
CT.gov ID
NCT05661318
Collaborator
(none)
5,000
Enrollment
1
Location
445
Anticipated Duration (Months)
11.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This Study is designed to assess CVD incidence, prevalence, progression and related risk factors, including genetic background. It will provide an important base for all cardiovascular research activities in our centre and help in designing future studies and guide policy.

Condition or Disease Intervention/Treatment Phase
  • Other: Risk assessment

Detailed Description

Background Population-based longitudinal studies are a cornerstone in understanding current disease landscapes affecting communities and collecting reliable data to guide prevention and treatment strategies. In Egypt there is pressing need of collecting reliable data on cardiovascular disease (CVD) in defined populations.

Objectives Defining the cardiovascular phenotype, genotype as well as OMICS and risk factors for CVD in a defined population in Egypt with follow up for up to 30 years

Methods As a first step, a random representative sample of 1,200 households from the Ballana population will be created. Following inclusion, patients will be screened for their cardiovascular profile and followed up for changes in their profile and cardiovascular events continuously every year in high risk patients and every 3 years for the rest of the participants for a period of 30 years.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
5000 participants
Observational Model:
Ecologic or Community
Time Perspective:
Prospective
Official Title:
Aswan Heart Centre - Ballana Heart Study
Actual Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Dec 31, 2050
Anticipated Study Completion Date :
Jan 31, 2055

Arms and Interventions

Arm Intervention/Treatment
BHS

Residents of Ballana from the 1,200 randomly selected households

Other: Risk assessment
Collect clinical, laboratoary and genetics data from the participants after informed consent

Outcome Measures

Primary Outcome Measures

  1. Cardiovascular risk assessment [30 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion criteria:

  • Residents of Ballana from the 1,200 randomly selected households

  • Participants must have a valid National ID card

  • Written informed consent

Exclusion criteria:

• Residents who are younger than 18 years

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aswan Heart Centre - Magdi Yacoub Heart Foundation Aswan Egypt

Sponsors and Collaborators

  • Magdi Yacoub Heart Foundation

Investigators

  • Principal Investigator: Magdi H Yacoub, FRS OM, Imperial College London, and Magdi Yacoub Heart Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Magdi Yacoub Heart Foundation
ClinicalTrials.gov Identifier:
NCT05661318
Other Study ID Numbers:
  • AHC-BHS
First Posted:
Dec 22, 2022
Last Update Posted:
Dec 22, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Magdi Yacoub Heart Foundation
genetics
Cardiovascular risks
Additional relevant MeSH terms:
Disease Susceptibility
Genetic Predisposition to Disease

Study Results

No Results Posted as of Dec 22, 2022