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OpenTrials
Completed

NCT Number: NCT05317845

An International Chart Review and Survey for the Prevalence and Clinical Management of Atherosclerotic Cardiovascular Diseases in Patients With Type 2 Diabetes Across Countries in the Middle East and Africa

The study is intended to estimate the proportion and clinical management of people with type 2 diabetes having atherosclerotic cardiovascular diseases or who are at high risk to develop atherosclerotic cardiovascular diseases.

Participants will be asked to give information about their health. Partipants will continue normal way of life and will not get any medication other than those prescribed to them by the doctor.

The study will last for about 6 months.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Manama, Bahrain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
  • Male or female, age greater than or equal to 18 years at the time of signing informed consent.
  • Diagnosed with T2D grater than or equal to 180 days prior to the day of signing informed consent

Exclusion criteria

  • Previous participation in this study. Participation is defined as having given informed consent in this study.
  • Mental incapacity, unwillingness, inability, or language barriers precluding adequate understanding or cooperation
  • Diagnosed with Type 1 Diabetes (T1D).
  • Patients with known congenital heart disease/malformation

Treatment and study plan

No treatment given

Other

The clinical management and prescribed treatment of diabetes and eASCVD/ASCVD risk factors are independent of this study and are part of the routine clinical practice at the discretion of the treating physician.

Primary outcomes

  1. Proportion of patients with Established Atherosclerotic Cardiovascular Disease (eASCVD) pooled across all countries and separately for each country in scope

    Time frame: At the time of patient enrolment (Day 1)

    Percentage patients

Secondary outcomes

  1. Proportion of T2D patients with high risk of Atherosclerotic cardiovascular disease (ASCVD) and without eASCVD

    Time frame: At the time of patient enrolment (Day 1)

    Percentage patients

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multi-center, Cross-sectional Chart Review and Survey to Capture the Prevalence and Clinical Management of Atherosclerotic Cardiovascular Diseases in Patients With Type 2 Diabetes Across Countries in the Middle East and Africa

Acronym: PACT-MEA

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 8, 2022
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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