NCT00970034

Brief Summary

The aim of this project is to determine the morphological criteria of apoptosis in atrial tissues of patients with AF versus SR at transcriptome and genomic size.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2009

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

September 3, 2009

Status Verified

September 1, 2009

First QC Date

September 1, 2009

Last Update Submit

September 2, 2009

Conditions

Keywords

Atrial fibrillation, apoptosis, oligonucleotide microarray

Outcome Measures

Primary Outcomes (1)

  • Expression profiles of genes related to apoptosis

    6 months

Secondary Outcomes (1)

  • Expression profiles of pro-apoptotic and anti-apoptotic proteins

    6 months

Study Arms (2)

AF

Patients with degenerative mitral valve regurgitation and permanent atrial fibrillation who require mitral valve repair or replacement.

SR

Patients with degenerative mitral valve regurgitation and maintaining sinus rhythm who require mitral valve repair or replacement.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Degenerative mitral valve regurgitation who require cardiac valve surgery

You may qualify if:

  • Patients with permanent atrial fibrillation or sinus rhythm and degenerative mitral valve regurgitation who require cardiac surgery
  • Pulmonary hypertension (systolic PA \> 45 mmHg)
  • Left ventricular ejection fraction \> 30%

You may not qualify if:

  • Paroxysmal AF or atrial flutter
  • Second or third degree heart block
  • Permanent pacemaker
  • Wolff-Parkinson-White syndrome
  • Brugada syndrome
  • Ischemic or rheumatic mitral valve disease
  • Dilated cardiomyopathy
  • LVEF \< 30%
  • Infective endocarditis, myocarditis
  • Trauma
  • Active HBV, HCV, HIV infection
  • Chronic renal failure
  • Autoimmune diseases
  • Vasculitis
  • Known genetic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Medical Faculty, Department of Cardiovascular Surgery,

Ankara, 06340, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Cubukcuoglu Deniz G, Durdu S, Dogan Y, Erdemli E, Ozdag H, Akar AR. Molecular Signatures of Human Chronic Atrial Fibrillation in Primary Mitral Regurgitation. Cardiovasc Ther. 2021 Oct 15;2021:5516185. doi: 10.1155/2021/5516185. eCollection 2021.

Biospecimen

Retention: SAMPLES WITH DNA

Human atrial tissue

MeSH Terms

Conditions

Mitral Valve InsufficiencyAtrial Fibrillation

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • RUCHAN A AKAR, Assoc. Prof.

    Ankara University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

RUCHAN AKAR, Assoc. Prof.

CONTACT

HILAL OZDAG, Assoc. Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2009

First Posted

September 2, 2009

Study Start

December 1, 2008

Study Completion

December 1, 2011

Last Updated

September 3, 2009

Record last verified: 2009-09

Locations