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Recruiting NCT06963567

Left Ventricular Thrombus Registry

Observational Left Ventricular Thrombus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Left Ventricular Thrombus. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Observational Registry to Determine the Predictors and Outcomes of Patients at Risk of and Diagnosed With Left Ventricular Thrombus

Overview

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.

Primary outcome measures

  • Composite Result [Time frame: From baseline to final 12 month follow up (+/- 2 months)]
Secondary outcome measures (3)
  • CMR prediction of thrombus [Time frame: From baseline to 6 month follow up (+/- 3 months)]
  • Blood Test [Time frame: From baseline to 6 month follow up (+/- 3 months)]
  • Quality of Life Questionnaire [Time frame: From baseline to final 12 month follow up (+/- 2 months)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United Kingdom · 8 centers
  • Royal Papworth Hospital — Cambridge
  • Basildon University Hospital — London
  • James Cook University Hospital — Middlesbrough
  • Sunderland Royal Hospital — Sunderland
  • Lancashire Cardiac Centre — Blackpool
  • Leeds General Infirmary — Leeds
  • St Bartholomew's Hospital — London
  • Imperial College Healthcare London — London

Identifiers

NCT: NCT06963567 · 336025 · G-002409

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗