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

NCT ID: NCT05873660

Last Updated: 2024-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5360 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-12

Study Completion Date

2024-06-24

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Overweight

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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People with established CVD

Adults diagnosed with established CVD, attending routine medical care or follow-up in a cardiology clinic.

No treatment given

Intervention Type OTHER

No treatment given

Interventions

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No treatment given

No treatment given

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Plainsboro, New Jersey, United States

Site Status

Novo Nordisk Investigational Site

São Paulo, , Brazil

Site Status

Novo Nordisk Investigational Site

Ontario, , Canada

Site Status

Novo Nordisk Investigational Site

Riyadh, , Saudi Arabia

Site Status

Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Countries

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United States Brazil Canada Saudi Arabia Spain

Other Identifiers

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U1111-1283-8551

Identifier Type: OTHER

Identifier Source: secondary_id

DAS-7537

Identifier Type: -

Identifier Source: org_study_id

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