InflammationCAIRNCT06411340
Inflammation in Acute Cardiovascular Diseases - the CArdiovascular Inflammation Registry (CAIR)
An observational study of Inflammation and Cardiovascular Diseases, run by King's College London.
Trial summary
Following acute cardiovascular injury, inflammation is vital to activate reparative mechanisms. However, there is compelling evidence implicating excessive inflammation and dysregulated resolution in fibrosis, ventricular remodelling, and heart failure (HF). Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Inflammation, Cardiovascular Diseases, Myocarditis
- What is being tested?
- Observation
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Jul 2039
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who are diagnosed with acute cardiovascular diseases can be included in the registry.
Who may be able to join
- Any patient 13 years of age or older with an acute cardiovascular condition requiring hospital admission is eligible.
Who cannot join
- <13 years of age
About this study
Official title: An Observational-based Registry of Routinely Collected Clinical Parameters to Study Inflammation in Acute Cardiovascular Diseases - the CArdiovascular Inflammation Registry
Following acute cardiovascular injury, inflammation is vital to activate reparative mechanisms. However, there is compelling evidence implicating excessive inflammation and dysregulated resolution in fibrosis, ventricular remodelling, and heart failure (HF). Recently, the anti-inflammatory agent colchicine reduced cardiovascular events after myocardial infarction (MI) compared to placebo, indicating that targeting inflammation in acute cardiovascular conditions is feasible. Several acute cardiovascular conditions are characterised by inflammation, including myocarditis, MI, and acute heart failure. However, there is large variability in definition, epidemiology, clinical presentation, pathophysiology, and natural history of acute inflammatory cardiovascular diseases. This relates, in part, to the difficulty in performing adequately powered studies. Clinical studies that include sufficient patients and extended observation periods are necessary to address some of these knowledge gaps. This registry aims to collate routinely collected clinical data on patients with acute cardiovascular diseases characterised by inflammation in an observational-based registry. By doing so, the investigators hope to understand the contribution of inflammation to the pathophysiology of acute cardiovascular disease, improve risk stratification, and identify potential novel therapeutic targets.
- Conditions
- Inflammation, Cardiovascular Diseases, Myocarditis, Pericarditis, Myocardial Infarction, Heart Failure
- Being tested
- Observation
- Keywords
- Inflammation, Acute cardiovascular disease, Myocarditis, Registry, Electronic health records, Pericarditis, Myocardial infarction
- Medical subject headings
- Inflammation, Cardiovascular Diseases, Myocarditis, Pericarditis, Myocardial Infarction, Heart Failure, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Observation
| Study group | Role | What they receive |
|---|---|---|
| Acute inflammatory cardiac disease | This registry aims to collate routinely collected clinical data on patients with acute cardiovascular diseases. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Primary outcome will include all-cause mortality, but will vary by specific research project conducted within the registry.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study startJul 2024 (estimated)
- Primary completionJul 2034 (estimated)
- Study completionJul 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by King's College LondonThe 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411340
- Sponsor's protocol ID
- 334636
- Acronym
- CAIR
- Status last verified
- May 2024
- First submitted
- 8 May 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Partner sites (including those outside the UK) will store linkage files for their own patients in accordance with local policies. Data will be stored on a research database (REDCap) hosted by King's College London. Each participating centre will have linkage codes for their own patients only. Therefore, exported data will not be identifiable to other centres.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational-based Registry of Routinely Collected Clinical Parameters to Study Inflammation in Acute Cardiovascular Diseases - the CArdiovascular Inflammation Registry
- ClinicalTrials.gov ID
- NCT06411340
- Acronym / sponsor ID
- CAIR / 334636
- Conditions
- Inflammation, Cardiovascular Diseases, Myocarditis, Pericarditis, Myocardial Infarction, Heart Failure
- Keywords
- Inflammation, Acute cardiovascular disease, Myocarditis, Registry, Electronic health records, Pericarditis, Myocardial infarction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2034 (estimated)
- Study completion
- Jul 2039 (estimated)
- First posted
- 13 May 2024 (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.
Following acute cardiovascular injury, inflammation is vital to activate reparative mechanisms. However, there is compelling evidence implicating excessive inflammation and dysregulated resolution in fibrosis, ventricular remodelling, and heart failure (HF). Recently, the anti-inflammatory agent colchicine reduced cardiovascular events after myocardial infarction (MI) compared to placebo, indicating that targeting inflammation in acute cardiovascular conditions is feasible. Several acute cardiovascular conditions are characterised by inflammation, including myocarditis, MI, and acute heart failure. However, there is large variability in definition, epidemiology, clinical presentation, pathophysiology, and natural history of acute inflammatory cardiovascular diseases. This relates, in part, to the difficulty in performing adequately powered studies. Clinical studies that include sufficient patients and extended observation periods are necessary to address some of these knowledge gaps. This registry aims to collate routinely collected clinical data on patients with acute cardiovascular diseases characterised by inflammation in an observational-based registry. By doing so, the investigators hope to understand the contribution of inflammation to the pathophysiology of acute cardiovascular disease, improve risk stratification, and identify potential novel therapeutic targets.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute inflammatory cardiac disease | – | Other: ObservationThis registry aims to collate routinely collected clinical data on patients with acute cardiovascular diseases. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are diagnosed with acute cardiovascular diseases can be included in the registry.
Key inclusion criteria (1 listed)
- Any patient 13 years of age or older with an acute cardiovascular condition requiring hospital admission is eligible.
Key exclusion criteria (1 listed)
- <13 years of age
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 |
|---|---|---|
| ObservationObservation | Other | Acute inflammatory cardiac disease |
Primary outcome
All-cause mortality
Time frame: 1 year
Primary outcome will include all-cause mortality, but will vary by specific research project conducted within the registry.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: No. Partner sites (including those outside the UK) will store linkage files for their own patients in accordance with local policies. Data will be stored on a research database (REDCap) hosted by King's College London. Each participating centre will have linkage codes for their own patients only. Therefore, exported data will not be identifiable to other centres.
Related trials for Inflammation
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation and Cardiovascular Diseases, run by King's College London.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
All-cause mortality (time frame: 1 year). 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 14 May 2024.