Inflammation in Acute Cardiovascular Diseases - the CArdiovascular Inflammation Registry (CAIR) (CAIR)
May 13, 2024 updated by: King's College London
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
1000
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients who are diagnosed with acute cardiovascular diseases can be included in the registry.
Description
Inclusion Criteria:
- Any patient 13 years of age or older with an acute cardiovascular condition requiring hospital admission is eligible.
Exclusion Criteria:
- <13 years of age
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 |
|---|---|
|
Acute inflammatory cardiac disease
This registry aims to collate routinely collected clinical data on patients with acute cardiovascular diseases.
|
Observation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Estimated)
July 1, 2024
Primary Completion (Estimated)
July 1, 2034
Study Completion (Estimated)
July 1, 2039
Study Registration Dates
First Submitted
May 8, 2024
First Submitted That Met QC Criteria
May 8, 2024
First Posted (Actual)
May 13, 2024
Study Record Updates
Last Update Posted (Actual)
May 14, 2024
Last Update Submitted That Met QC Criteria
May 13, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 334636
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
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.