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

June 14, 2023 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

5360

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 Locations

  • Brazil
      • São Paulo, Brazil
        • Novo Nordisk Investigational Site
  • Canada
      • Ontario, Canada
        • Novo Nordisk Investigational Site
  • Saudi Arabia
      • Riyadh, Saudi Arabia
        • Novo Nordisk Investigational Site
  • Spain
      • Madrid, Spain
        • Novo Nordisk Investigational Site
  • United States
    • New Jersey
      • Plainsboro, New Jersey, United States, 08536
        • Novo Nordisk Investigational Site

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of adults aged 18 years or older diagnosed with established cardiovascular disease (CVD) and are attending routine medical care or follow-up in a cardiology clinic.

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
People with established CVD
Adults diagnosed with established CVD, attending routine medical care or follow-up in a cardiology clinic.
Other: No treatment given
No treatment given

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overweight and obesity among patients with established CVD pooled across all countries
Time Frame: At the time of patient enrolment (Day 1/Visit 1)
% of patients
At the time of patient enrolment (Day 1/Visit 1)

Collaborators and Investigators

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

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

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)

June 12, 2023

Primary Completion (Estimated)

June 4, 2024

Study Completion (Estimated)

June 4, 2024

Study Registration Dates

First Submitted

May 15, 2023

First Submitted That Met QC Criteria

May 15, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 14, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAS-7537
  • U1111-1283-8551 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"

Drug and device information, study documents

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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