A Study to Characterize the Prevalence of Overweight and Obesity Among Patients With Established Cardiovascular Disease.

Obesity Clinical Trial

— POETIC  

Official title:

Multi-centre Cross-sectional Observational Study to Characterize the Prevalence of Overweight and Obesity Among Patients With Established Cardiovascular Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05873660
• Other study ID #: DAS-7537
• Secondary ID: U1111-1283-8551
• Status: Enrolling by invitation
• Start date: June 12, 2023
• Est. completion date: June 4, 2024

Study information

• Verified date: June 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this observational study is to measure how many people are overweight or obese amongst patients with a diagnosed cardiovascular disease (CVD). The study also aims to characterise the population including the presence of cardiovascular (CV) risk factors in a number of countries across the globe representing different geographies, ethnicities, as well as different healthcare systems.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 5360
• Est. completion date: June 4, 2024
• Est. primary completion date: June 4, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).

2. Adults, age above or equal to 18 years at the time of signing informed consent.

3. Have established CVD and equal to or greater than 1 follow up appointment following an

acute event from at least one of the following:

• Prior myocardial infarction
• Prior stroke (ischemic or haemorrhagic stroke)
• Symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) below 85 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having given informed consent in this study

2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

3. Patients with known congenital heart disease/malformation

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Obesity
• Overweight

Intervention

Other:
• No treatment given
No treatment given

Locations

Country	Name	City	State
Brazil	Novo Nordisk Investigational Site	São Paulo
Canada	Novo Nordisk Investigational Site	Ontario
Saudi Arabia	Novo Nordisk Investigational Site	Riyadh
Spain	Novo Nordisk Investigational Site	Madrid
United States	Novo Nordisk Investigational Site	Plainsboro	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  Saudi Arabia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overweight and obesity among patients with established CVD pooled across all countries	% of patients	At the time of patient enrolment (Day 1/Visit 1)