NCT06963567

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started May 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress73%
May 2024Jan 2027

Study Start

First participant enrolled

May 17, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 9, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

2.7 years

First QC Date

April 30, 2025

Last Update Submit

May 5, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Composite Result

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

    From baseline to final 12 month follow up (+/- 2 months)

Secondary Outcomes (3)

  • CMR prediction of thrombus

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

  • Blood Test

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

  • Quality of Life Questionnaire

    From baseline to final 12 month follow up (+/- 2 months)

Study Arms (2)

LV Thrombus (present)

Patients with a diagnosis of LV thrombus in the setting of LV dysfunction (acute myocardial infarction, Ischaemic Cardiomyopathy (ICM), dilated cardiomyopathy (DCM)).

LV Thrombus (at risk)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • Patients with LV thrombus or;
  • Patients at risk for developing LV thrombus (e.g severe LV dysfunction, LV aneurysm, MI.

You may not qualify if:

  • Age \< 18 years
  • Unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2025

First Posted

May 9, 2025

Study Start

May 17, 2024

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations