Left Ventricular Thrombus Registry
ConditionLeft Ventricular Thrombus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorQueen Mary University of London
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients with LV thrombus or;
Patients at risk for developing LV thrombus (e.g severe LV dysfunction, LV aneurysm, MI.
Disqualifiers
Age < 18 years
Unable to consent
Trial population
Patients with a diagnosis of LV thrombus in the setting of LV dysfunction (acute myocardial infarction, Ischaemic Cardiomyopathy (ICM), dilated cardiomyopathy (DCM)) will be screened. Patients that do not have LV thrombus but are at risk for developing thrombus such as those with severe LV dysfunction, LV aneurysms, large territory infarcts will also be included.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
1,500 Participants
are grouped into 2 trial groupsGroup A: LV Thrombus (present)
Group B: LV Thrombus (at risk)
Trial outcomes
Primary outcomes
1
Composite Result
To measure the composite result of major bleeding (BARC \>3), stroke and systemic embolisation, and all-cause mortality
Time frame
From baseline to final 12 month follow up (+/- 2 months)Secondary outcomes
1
CMR prediction of thrombus
To assess CMR based risk prediction model of recurrence of LV thrombus
Time frame
From baseline to 6 month follow up (+/- 3 months)2
Blood Test
To assess blood test variables in the persistence or recurrence of LV thrombus
Time frame
From baseline to 6 month follow up (+/- 3 months)3
Quality of Life Questionnaire
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
Time frame
From baseline to final 12 month follow up (+/- 2 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov