Atrial Fibrillation Driver Study

NCT05743829 | Unknown

• 1 other identifier: RHM CAR0630
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

Atrial Fibrillation (AF) is an abnormal rhythm of the heart which is increasingly common and can be associated with serious consequences. We know that AF is associated with an increase in the scarring of the heart, the left atrium and it is thought that this scarring may be one of the drivers for this abnormal heart rhythm. The nature of this scarring in humans has been subject to limited study and generally only by indirect means such as cardiac MRI scans or measuring the voltage of the tissues. During cardiothoracic surgery, tissue from the left atrium is removed as a part of the procedure. This tissue is normally disposed of, but we would propose to consent patients to collect it to allow it to be analysed. Such analysis would examine the composition of the tissue, including the pattern of scarring, to allow us to gain a greater insight into the mechanisms of AF.

Conditions

Atrial Fibrillation; Fibrosis Myocardial

Keywords

AF; Fibrosis

Outcome Measures

Primary Outcomes (2)

• Histological analysis

  Immunohistochemistry, in situ hybridisation, electron microscopy, collagen cross-linking

  1 year

• Molecular analysis

  genome sequencing, miRNA and RNA sequencing, culture, RT-PCR, flow cytometry and immunocytochemistry

  1 year

Study Arms (2)

Cardiac Surgery

Patients undergoing cardiac surgery - left atrial appendage excision

Procedure: Tissue excision as part of routine clinical care

Thoracic Surgery

Patients undergoing lung resection - ostial pulmonary vein tissue

Procedure: Tissue excision as part of routine clinical care

Interventions

Tissue excision as part of routine clinical care PROCEDURE

Tissue excision

Cardiac Surgery; Thoracic Surgery

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing cardiac and thoracic surgery

You may qualify if:

• Able to provide informed consent for study
• Male or female subjects between 18 and 100 years of age at the time of consent.
• Thoracic surgical patients either with or without a history of AF undergoing lung resection where an ostial pulmonary vein segment will be excised as part of this resection

You may not qualify if:

• Patient unable or unwilling to consent
• Patient not having ostial pulmonary vein or left atrial appendage tissue excised as part of routine clinical care.

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

Biospecimen

Retention: SAMPLES WITH DNA

In all cases tissue that is surplus to the clinical requirement will be obtained if available. This tissue will be either processed for histological analyses (including embedding for immunohistochemistry, in situ hybridisation, electron microscopy), flash frozen in liquid nitrogen for assays including collagen cross-linking, or cultured in vitro and stimulated with relevant stimuli. These analyses may be complemented by additional assays (including but not limited to) for genome sequencing, miRNA and RNA sequencing, culture, RT-PCR, flow cytometry and immunocytochemistry. Cells established in culture will also be stored in liquid nitrogen for experimental investigations at later dates.

MeSH Terms

Conditions

Atrial Fibrillation; Fibrosis

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Waqas Ullah

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Waqas Ullah, PhD

CONTACT

07941461222; waqas@doctors.org.uk

Study Design

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

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 24, 2023
• Study Start: March 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: February 24, 2023

Record last verified: 2023-02