Atherosclerotic Cardiovascular Disease (ASCVD)FLAME-ASCVDNCT05755373
A Multinational Survey-based Study to Understand the Real-world Awareness and Perceptions of Systemic inFLAMmation and rolE of hsCRP as a Biomarker in Patients With AtheroSclerotic CardioVascular Disease and Chronic Kidney Disease Among Cardiologists
An observational study of Atherosclerotic Cardiovascular Disease (ASCVD) and Chronic Kidney Disease (CKD), run by Novo Nordisk A/S at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease (ASCVD), Chronic Kidney Disease (CKD)
- What is being tested?
- No treatment given
- How many people
- 602 participants
- Where
- 1 siteIndia
- Study dates
- 24 Mar 2023to 15 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiologists treating patients with ASCVD and CKD
Who may be able to join
- 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 above or equal to 18 years at the time of signing informed consent.
- Is a Cardiologist.
- Has been in practice greater than or equal to 3 years.
- Sees at least 15 ASCVD and CKD patients per month.
Who cannot join
- Previous participation in this study. Participation is defined as having given informed consent in this study
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Does not meet inclusion criteria requirements
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- No treatment given
- Medical subject headings
- Atherosclerosis, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenOther
No treatment given
| Study group | Role | What they receive |
|---|---|---|
| Cardiologists | Cardiologists treating patients with ASCVD and CKD Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiologists' perceptions towards the role of systemic inflammation in the identification, treatment and management of patients with ASCVD and CKD. Multi-select from a defined list.
Numerical; A 7-point Likert scale for measurement of agreement from 1 "strongly disagree" to 7 "strongly agree".
Measured: At the time of survey response (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start24 Mar 2023
- Primary completion15 May 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular Disease (ASCVD)Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755373
- Sponsor's protocol ID
- DAS-7672
- Other IDs
- U1111-1284-5885
- Acronym
- FLAME-ASCVD
- Status last verified
- Jun 2023
- First submitted
- 23 Feb 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational Survey-based Study to Understand the Real-world Awareness and Perceptions of Systemic inFLAMmation and rolE of hsCRP as a Biomarker in Patients With AtheroSclerotic CardioVascular Disease and Chronic Kidney Disease Among Cardiologists
- ClinicalTrials.gov ID
- NCT05755373
- Acronym / sponsor ID
- FLAME-ASCVD / DAS-7672
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 602 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2023 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiologists | – | Other: No treatment givenCardiologists treating patients with ASCVD and CKD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiologists treating patients with ASCVD and CKD
Key inclusion criteria (5 listed)
- 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 above or equal to 18 years at the time of signing informed consent.
- Is a Cardiologist.
- Has been in practice greater than or equal to 3 years.
- Sees at least 15 ASCVD and CKD patients per month.
Key exclusion criteria (3 listed)
- Previous participation in this study. Participation is defined as having given informed consent in this study
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Does not meet inclusion criteria requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No treatment givenNo treatment given | Other | Cardiologists |
Primary outcome
Cardiologists' perceptions towards the role of systemic inflammation in the identification, treatment and management of patients with ASCVD and CKD. Multi-select from a defined list.
Time frame: At the time of survey response (Day 1)
Numerical; A 7-point Likert scale for measurement of agreement from 1 "strongly disagree" to 7 "strongly agree".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Related trials for Atherosclerotic Cardiovascular Disease (ASCVD)
Active, not recruitingPhase 3
Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial
Atherosclerotic Cardiovascular Disease
Not yet recruitingPhase 2
A Phase II Study of FXR0906 in Patients With Severe Hypertriglyceridemia or Hypertriglyceridemia With ASCVD.
sHTG, HTG With ASCVD (Diagnosed or at Increased Risk)
Recruiting
Test 2 Treat: Can we Improve the Testing and Treatment of High Cholesterol in Patients Who Have Been Hospitalized for a Cardiac Event by Providing Education to Doctors and Patients?
ASCVD, LDL-C
Active, not recruitingPhase 2
Phase 2 Study of Kylo-11 in ASCVD Patients With Elevated Lp(a)
Lipoprotein Disorder
Active, not recruitingPhase 3
Pelacarsen Roll-over Extension Program
Atherosclerotic Cardiovascular Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerotic Cardiovascular Disease (ASCVD) and Chronic Kidney Disease (CKD), run by Novo Nordisk A/S at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiologists' perceptions towards the role of systemic inflammation in the identification, treatment and management of patients with ASCVD and CKD. Multi-select from a defined list. (time frame: At the time of survey response (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.