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Clinical Outcomes After Acute Pulmonary Embolism

NCT ID: NCT04355975

Last Updated: 2022-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-01

Study Completion Date

2030-12-31

Brief Summary

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To investigate safety and effectiveness of PE treatment according to the decision of the multi-disciplinary pulmonary embolism response team (PERT) and to define and optimize treatment indications, institutional algorithms and interventional techniques for PE.

Detailed Description

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This single-center cohort study is designed to retrospectively and prospectively collect treatment and outcome data related to patients with PE and after activation of the PERT. Treatment information and outcomes after advanced treatment modalities, including systemic thrombolysis, catheter directed thrombolysis and surgical embolectomy, will be collected.

Retrospective patient data will consist of treatment and health related outcomes of consecutive patients treated for acute and chronic PE between October 2017 and April 2020 (to assess the learning curve of the PERT) and of patients receiving surgical embolectomy between January 2001 and April 2020. The retrospective data will be derived from the local institutional dataset and will be transferred to the study database. Prospective patients will be included after May 2020.

Conditions

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Pulmonary Embolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Medical Therapy / Anticoagulation

No interventions assigned to this group

Systemic Lysis

No interventions assigned to this group

Interventional Therapy for PE

No interventions assigned to this group

Surgical Embolectomy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Consecutive patients with pulmonary embolism matching the criteria for treatment according to the decision of the PERT.
* Written informed consent

Exclusion Criteria

* High probability of non-adherence to the follow up requirements
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefan Stortecky, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Bern University Hospital, University of Bern, Switzerland

Locations

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University Hospital Bern - Inselspital

Bern, Canton of Bern, Switzerland

Site Status RECRUITING

University Hospital Bern

Bern, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Stefan Stortecky, MD

Role: CONTACT

Phone: +41 31 632 21 11

Email: [email protected]

Facility Contacts

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Stefan Stortecky, MD

Role: primary

Stefan Stortecky, MD

Role: primary

References

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Draxler DF, Johannes JK, Nakase M, Heg D, Dobner S, Turovskij E, Furholz M, Haner J, Lanz J, Pilgrim T, Hunziker L, Praz F, Raber L, Rohla M, Siontis GCM, Susuri-Pfammatter N, Windecker S, Stortecky S. Clinical Outcomes in Patients With Acute Pulmonary Embolism Undergoing Ultrasound-Assisted Catheter-Directed Thrombolysis. J Am Heart Assoc. 2025 May 6;14(9):e035916. doi: 10.1161/JAHA.124.035916. Epub 2025 Apr 25.

Reference Type DERIVED
PMID: 40281654 (View on PubMed)

Other Identifiers

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4303 - 2019-02042

Identifier Type: -

Identifier Source: org_study_id