AHC Ballana Heart Study (AHC-BHS)

December 14, 2022 updated by: Magdi Yacoub Heart Foundation

Aswan Heart Centre - Ballana Heart Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Aswan, Egypt
        • Recruiting
        • Aswan Heart Centre - Magdi Yacoub Heart Foundation
        • Contact:
        • Contact:
        • Principal Investigator:
          • Magdi H Yacoub, OM FRS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular risk assessment
Time Frame: 30 years
30 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Magdi Yacoub Heart Foundation

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Anticipated)

December 31, 2050

Study Completion (Anticipated)

January 31, 2055

Study Registration Dates

First Submitted

December 14, 2022

First Submitted That Met QC Criteria

December 14, 2022

First Posted (Estimate)

December 22, 2022

Study Record Updates

Last Update Posted (Estimate)

December 22, 2022

Last Update Submitted That Met QC Criteria

December 14, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHC-BHS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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