Cohort of Patients With Left Ventricular Thrombus: Management and Outcomes in the Direct Oral Anticoagulants Era

NCT05028777 | Recruiting

• 1 other identifier: 2020-02187
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators' primary objective is to assess whether a difference in the occurrence of bleeding events exist between patients with LVT treated with DOACs as compared to those treated with VKAs.

Conditions

Thrombus of Left Ventricle

Keywords

Left Ventricular Assist Device; Acute Myocardial Infarction; Left Ventricular or Left Ventricle; Dual Antiplatelet Therapy; Direct Oral Anticoagulant

Outcome Measures

Primary Outcomes (1)

• The occurrence at 1 year of bleeding

  Primary combined endpoint includes the occurrence at 1 year of bleeding BARC (Bleeding Academic Research) Consortium type 2, 3 or 5.

  1 year

Secondary Outcomes (8)

• Rate of patients with arterial systemic embolic event

  1, 2 and 5 years

• Rate of patients with ischemic stroke

  1, 2 and 5 years

• Rate of patients with myocardial infraction

  1, 2 and 5 years

• Rate of patients with peripheral embolism

  1, 2 and 5 years

• Rate of patients with transient ischemic attack

  1, 2 and 5 years

Study Arms (1)

Patients diagnosed with left ventricular thrombus

All patients diagnosed with left ventricular thrombus through different imaging modalities (echocardiography, CT or MRI) and who have been diagnosed and/or treated at the Inselspital or another site of the Insel Gruppe.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is an observational, retrospective and prospective, monocentric study including all patients diagnosed with left ventricular thrombus through different imaging modalities (echocardiography, CT or MRI)

You may qualify if:

• Patients at least 18 years old at enrolment
• With a LVT identified at echocardiography, MRI or CT between January 1st, 2013 and July 31st, 2020
• Treated at least once at the Inselspital or in another site of the Insel Gruppe
• Able to provide a written informed consent

You may not qualify if:

• Documented refusal

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Cardiology, University Hospital Bern

Bern, 3010, Switzerland

RECRUITING

Study Officials

• Christoph Gräni, Prof. PHD

  Department of Cardiology, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph Gräni, Prof. PHD

CONTACT

+41 31 632 4508; christoph.graeni@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: August 31, 2021
• Study Start: January 1, 2021
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)