NCT06411340

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
160mo left

Started Jul 2024

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Jul 2024Jul 2039

First Submitted

Initial submission to the registry

May 8, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 13, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2034

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2039

Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

10 years

First QC Date

May 8, 2024

Last Update Submit

May 13, 2024

Conditions

Keywords

InflammationAcute cardiovascular diseaseMyocarditisRegistryElectronic health recordsPericarditisMyocardial infarction

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    Primary outcome will include all-cause mortality, but will vary by specific research project conducted within the registry.

    1 year

Study Arms (1)

Acute inflammatory cardiac disease

This registry aims to collate routinely collected clinical data on patients with acute cardiovascular diseases.

Other: Observation

Interventions

Observation

Acute inflammatory cardiac disease

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are diagnosed with acute cardiovascular diseases can be included in the registry.

You may qualify if:

  • Any patient 13 years of age or older with an acute cardiovascular condition requiring hospital admission is eligible.

You may not qualify if:

  • \<13 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

InflammationCardiovascular DiseasesMyocarditisPericarditisMyocardial InfarctionHeart FailureHeart Diseases

Interventions

Observation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsCardiomyopathiesMyocardial IschemiaVascular DiseasesInfarctionIschemiaNecrosis

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2024

First Posted

May 13, 2024

Study Start

July 1, 2024

Primary Completion (Estimated)

July 1, 2034

Study Completion (Estimated)

July 1, 2039

Last Updated

May 14, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

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.