PACT-MEA: 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
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with Type 2 Diabetes (T2D) Selected for inclusion in the study by their primary or secondary care physicians |
Other: No treatment given
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.
|
Outcome Measures
Primary Outcome Measures
- Proportion of patients with Established Atherosclerotic Cardiovascular Disease (eASCVD) pooled across all countries and separately for each country in scope [At the time of patient enrolment (Day 1)]
Percentage patients
Secondary Outcome Measures
- Proportion of T2D patients with high risk of Atherosclerotic cardiovascular disease (ASCVD) and without eASCVD [At the time of patient enrolment (Day 1)]
Percentage patients
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Manama | Bahrain | ||
| 2 | Novo Nordisk Investigational Site | Alexandria | Egypt | ||
| 3 | Novo Nordisk Investigational Site | Amman | Jordan | ||
| 4 | Novo Nordisk Investigational Site | Salmiya | Kuwait | ||
| 5 | Novo Nordisk Investigational Site | Doha | Qatar | ||
| 6 | Novo Nordisk Investigational Site | Johannesburg | South Africa | ||
| 7 | Novo Nordisk Investigational Site | Abu Dhabi | United Arab Emirates |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DAS-007
- U1111-1266-5511