Prospective clinical trial to elucidate the association between symptomatic atrial fibrillation and arterial stiffness and analysis of its clinical relevance
- Conditions
- Personality traitPerceptionRecurrenceI48Atrial fibrillation and flutter
- Registration Number
- DRKS00019007
- Lead Sponsor
- niversitätsklinikum Mannheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 168
male and female pts = 18 years, with atrial fibrillation, written informed consent
Unstable Angina pectoris / Acute Myocardial Infarction / Cardiogenic Shock
Indications for operative coronary revascularization (bypass surgery)
Stroke or TIA
Resting heart rate <50 beats per minute
Presence of a pacemaker / AICD and other metallic implants
Valve vitium with indication for surgery
Sick sinus syndrome, SA block, AV block III
Uncontrolled hypertension
Severe hypotension (<90 / 50mmHg)
Severe hepatic insufficiency
Patients with heart failure NYHA class III - IV
Pacemaker dependency
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical symptoms (measurement method: questionnaire, interview)<br>Aortic distensibility (measurement method: echocardiography transthoracic / transesophageal)<br>Pulse wave velocity and augmentation index (measurement method: pulse wave analysis using a tonometrically recorded pulse curve).<br><br>The primary endpoint is collected only once at the beginning of the study.
- Secondary Outcome Measures
Name Time Method aboratory measured parameters for oxidative stress and inflammation (50 ml blood, 3xLi-Hep, 3xCitrate, 3xEDTA): VCAM-1, ICAM-1, MCP-1, TNF-alpha, IL-6, hs-CRP (measurement method: ELISA)<br><br>Personality trait (measurement method: questionnaire 5 BT, interview).<br><br>The secondary endpoint is collected only once at the beginning of the study.