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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06411340
Other study ID # 334636
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 2024
Est. completion date July 2039

Study information

Verified date May 2024
Source King's College London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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). 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1000
Est. completion date July 2039
Est. primary completion date July 2034
Accepts healthy volunteers No
Gender All
Age group 13 Years and older
Eligibility 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 Design


Intervention

Other:
Observation
Observation

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
King's College London

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause mortality Primary outcome will include all-cause mortality, but will vary by specific research project conducted within the registry. 1 year
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