Atrial Electromechanical Interval and Pulse Wave Velocity in the Prediction of Recurrence of Atrial Fibrillation (APPRAISE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Creighton University
Sponsor:
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT00818012
First received: January 6, 2009
Last updated: March 28, 2013
Last verified: March 2013
  Purpose

This study aims to evaluate the utility of the atrial electromechanical interval and pulse wave velocity in the prediction of recurrence of atrial fibrillation among patients who underwent successful direct current cardioversion for atrial fibrillation.


Condition
Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Atrial Electromechanical Interval and Pulse Wave Velocity in the Prediction of Recurrence of Atrial Fibrillation In Patients Undergoing Successful Electrical Cardioversion to Sinus Rhythm

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • Recurrence of Atrial Fibrillation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: August 2008
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Detailed Description:

This will be a prospective cohort study designed to evaluate the value of atrial electromechanical interval and pulse wave velocity in the prediction of recurrence of atrial fibrillation among patients with atrial fibrillation with successful direct-current cardioversion to sinus rhythm.

Should cardioversion be successful, a limited 2D echocardiogram will be done and the following information will be measured: atrial electromechanical interval, left atrial volume, left atrial size, ejection fraction, and maximal A-wave transmitral Doppler flow velocity. The presence of left ventricular hypertrophy and valvular heart disease will be recorded. In addition, baseline clinical information including age, gender, medications, presence of HTN, DM, CAD, stroke, and prior history of atrial fibrillation will be obtained.

Radial artery applanation tonometry and pulse wave analysis will be used to calculate a central aortic pressure and other parameters using commercially available SphygmoCor® system. Central aortic pressures will be obtained immediately following measurement of brachial artery pressures. Patients will be seated for 5 minutes in a quiet room after which time blood pressure will be measured over the brachial artery three times at 5 minute intervals. The mean of the last two measurements will be recorded as representative of the brachial artery pressure. After the last measurement, radial artery pressure waveforms of the same arm will be sampled over 10 seconds with a Millar tonometer and calibrated to the average brachial pressure. Waveforms will be processed with dedicated software (SphygmoCor® version 7, AtCor). The software will be used to calculate an averaged radial artery waveform and to derive a corresponding central aortic pressure. Aortic pressure waveforms will be subjected to further analysis by the SphygmoCor® software to identify the time to the peak/shoulder of the first and second pressure wave components (T1, T2) during systole. The pressure at the peak/shoulder of the first component sill be identified as P1 height (outgoing pressure wave) and the pressure difference between P1 and the maximal pressure during systole (∆P or augmentation) will be identified as the reflected pressure wave occurring during systole. Augmentation index (AIx), defined as the ratio of augmentation to central pulse pressure, will be expressed as the percentage: AIx = (∆P/PP) x 100, where P is pressure and PP is pulse pressure. Pulse pressure amplification (PPA) will be expressed as the ratio of central pulse pressure (CPP) to peripheral (brachial) pulse pressure (PPP): PPA = PPP/CPP

Information will be recorded and the patients will be followed by their respective cardiologists and evaluated for recurrence of atrial fibrillation within 6 months.

Primary endpoint for this study is clinical recurrence of atrial fibrillation or 6 month time frame of sustained maintenance of sinus rhythm whichever comes first.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients in Atrial Fibrillation

Criteria

Inclusion Criteria:

  • Age greater than or equal to 19 years of age
  • History of atrial fibrillation with successful cardioversion to sinus rhythm
  • Informed consent to participate in the study

Exclusion Criteria:

  • Failure of cardioversion to sinus rhythm
  • Use of anti-arrythmic drug therapy
  • Refusal to participate in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818012

Contacts
Contact: Kyle Ulveling, MD 402-280-4566

Locations
United States, Nebraska
Creighton University Medical Center Recruiting
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Investigators
Principal Investigator: Kyle Ulveling, MD Creighton University Medical Center
  More Information

No publications provided

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00818012     History of Changes
Other Study ID Numbers: 08-15050
Study First Received: January 6, 2009
Last Updated: March 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
atrial fibrillation
atrial electromechanical interval
direct current cardioversion
pulse wave velocity

Additional relevant MeSH terms:
Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes

ClinicalTrials.gov processed this record on July 20, 2014