A Study to Understand the Real-world Awareness and Perceptions for Systemic Inflammation and Usage of hsCRP in Patients With Atherosclerotic Cardiovascular Disease (ASCVD) and Chronic Kidney Disease (CKD) Among Cardiologists

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05755373
• Collaborator: (none)
• Enrollment: 612
• Location: 1
• Anticipated Duration (Months): 1.1
• Patients Per Site Per Month: 547.9

Study Details

Study Description

Brief Summary

The purpose of this survey is to collect information for scientific research and to better understand the role of systemic inflammation in identification, treatment and management of patients with ASCVD and CKD.

This study is a cross-sectional design conducted among cardiologists in United Kingdom, Italy, Germany, Brazil, Saudi Arabia, Japan, Australia, China, India and France, treating ASCVD and CKD patients. Study participants will be recruited to complete an approximately 20-minute self-administered online survey. Recruitment will be conducted through email and phone. Data is collected though online data collection using a programmed survey.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerotic Cardiovascular Disease (ASCVD); Chronic Kidney Disease (CKD)	Other: No treatment given

Study Design

• Study Type: Observational
• Anticipated Enrollment: 612 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: A Multinational Survey-based Study to Understand the Real-world Awareness and Perceptions for Systemic Inflammation and Usage of hsCRP in Patients With Atherosclerotic Cardiovascular Disease (ASCVD) and Chronic Kidney Disease (CKD) Among Cardiologists
• Anticipated Study Start Date: Apr 10, 2023
• Anticipated Primary Completion Date: May 14, 2023
• Anticipated Study Completion Date: May 14, 2023

Arms and Interventions

Arm	Intervention/Treatment
Cardiologists Cardiologists treating patients with ASCVD and CKD	Other: No treatment given; No treatment given

Outcome Measures

Primary Outcome Measures

1. Cardiologists' perceptions towards the role of systemic inflammation in the identification, treatment and management of patients with ASCVD and CKD [At the time of survey response (Day 1)]

   Multi-select from a defined list; Numerical

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

3. Is a Cardiologist.

4. Has been in practice greater than or equal to 3 years.

5. Sees at least 15 ASCVD and CKD patients per month.

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. Does not meet inclusion criteria requirements

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Bangalore		India

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.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT05755373
• Other Study ID Numbers: DAS-7672; U1111-1284-5885
• First Posted: Mar 6, 2023
• Last Update Posted: Mar 6, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Cardiovascular Diseases; Atherosclerosis; Inflammation

Study Results

No Results Posted as of Mar 6, 2023