Effect of Ischemic Preconditioning on Atrial Fibrillation After Electrocardioversion

NCT ID: NCT05342220

Last Updated: 2024-07-09

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

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2024-06-30

Brief Summary

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Remote ischemic preconditioning is one way to influence the success of therapy in cardiovascular patients. By means of remote ischemic preconditioning the incidence of atrial fibrillation after cardiac surgery was reduced by 54%. The investigators aim to investigate the effect of ischemic preconditioning in an easy-to-perform protocol with regard to the recurrence of atrial fibrillation after electrical cardioversion.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Remote Ischemic Preconditioning

Remote ischemic preconditioining

Group Type ACTIVE_COMPARATOR

Remote ischemic preconditioning

Intervention Type PROCEDURE

Remote ischemic preconditioning through inflation of a blood pressure cuff to pressure values \> 200mmHg for 5 minutes followed by 5 minutes of reperfusion (3 times each) before electrocardioversion Electrical cardioversion for atrial fibrillation (100, 150, 200 Joule)

Control

Sham preconditioning

Group Type SHAM_COMPARATOR

Sham preconditioning

Intervention Type PROCEDURE

Inflation of a blood pressure cuff to pressure values \~ 10mmHg for 5 minutes followed by 5 minutes of reperfusion (3 times each) before electrocardioversion

Interventions

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Remote ischemic preconditioning

Remote ischemic preconditioning through inflation of a blood pressure cuff to pressure values \> 200mmHg for 5 minutes followed by 5 minutes of reperfusion (3 times each) before electrocardioversion Electrical cardioversion for atrial fibrillation (100, 150, 200 Joule)

Intervention Type PROCEDURE

Sham preconditioning

Inflation of a blood pressure cuff to pressure values \~ 10mmHg for 5 minutes followed by 5 minutes of reperfusion (3 times each) before electrocardioversion

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with paroxysmal or persistent atrial fibrillation who give written informed consent to participate in the study
* Age \> 18 years
* Consent capacity

Exclusion Criteria

* Age under 18 years
* Pregnancy
* Lack of consent capacity
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Josefs-Hospital Wiesbaden GmbH

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St. Josefs-Hospital Wiesbaden

Wiesbaden, Hesse, Germany

Site Status

Countries

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Germany

References

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Keim C, Wiedenmann L, Schubert T, Rothe M, Dobre BC, Kaess BM, Ehrlich JR, Boehmer AA. Remote Ischemic Preconditioning for Electrical Cardioversion of Atrial Fibrillation-the Prospective Randomized PRECON-AF Study. CJC Open. 2025 Mar 10;7(5):571-578. doi: 10.1016/j.cjco.2025.03.004. eCollection 2025 May.

Reference Type DERIVED
PMID: 40433224 (View on PubMed)

Other Identifiers

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PRECON

Identifier Type: -

Identifier Source: org_study_id

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