MedPath

Left Ventricular Thrombus Registry

Recruiting
Conditions
Left Ventricular Thrombus
Registration Number
NCT06963567
Lead Sponsor
Queen Mary University of London
Brief Summary

Left Ventricular Thrombus (LVT) is a blood clot that can develop in a poorly functioning heart. In around 1 in 6 patients who have had a heart attack or diagnosed with heart failure tend to develop blood clots in their main heart chamber.

Having a blot clot in the main heart chamber can lead to serious complications such as stroke. Treatment for blood clots is blood thinning medications, which if taken for a prolonged period of time can result in bleeding which further complicates treatment. We hope to gather information to better understand the factors associated with blood clot formation and management in the lower left chamber of the heart. This understanding will hopefully enable us and others to improve management of this condition in the future and therefore help the wider population. As part of this study, bloods and scan results will be recorded and we will complete a short quality of life questionnaire. When participants come in for routine MRI scan, we may capture additional images for further research analysis.

A sample of blood no more than one tablespoon will be collected for research analysis at the same time as routine blood test. This will occur at baseline and at around 6 months. At 12 months we will repeat the quality of life questionnaire and collect final data.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
1500
Inclusion Criteria
  • Patients with LV thrombus or;
  • Patients at risk for developing LV thrombus (e.g severe LV dysfunction, LV aneurysm, MI.
Exclusion Criteria
  • Age < 18 years
  • Unable to consent

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Composite ResultFrom baseline to final 12 month follow up (+/- 2 months)

To measure the composite result of major bleeding (BARC \>3), stroke and systemic embolisation, and all-cause mortality

Secondary Outcome Measures
NameTimeMethod
CMR prediction of thrombusFrom baseline to 6 month follow up (+/- 3 months)

To assess CMR based risk prediction model of recurrence of LV thrombus

Blood TestFrom baseline to 6 month follow up (+/- 3 months)

To assess blood test variables in the persistence or recurrence of LV thrombus

Quality of Life QuestionnaireFrom baseline to final 12 month follow up (+/- 2 months)

Participants quality of life (QoL) will be measured using European Quality of Life-5 Dimensions - 5 levels (EQ-5D-5L) questionnaire at baseline and 12 months

Trial Locations

Locations (1)

St Bartholomew's Hospital

🇬🇧

London, United Kingdom

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