We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Left Atrial Distensibility to Predict Prognosis in Consecutive Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01171040
Recruitment Status : Unknown
Verified July 2009 by Kaohsiung Veterans General Hospital..
Recruitment status was:  Recruiting
First Posted : July 28, 2010
Last Update Posted : March 8, 2011
Sponsor:
Information provided by:
Kaohsiung Veterans General Hospital.

Brief Summary:
Left ventricular filling pressure (LVFP) has prognostic significance in patients with heart failure. Traditionally, it should be assessed by invasive method, as cardiac catheterization and Swan-Gung catheter. In advance of new techniques and modality, echocardiography provides some useful parameters for assessing LVFP, such myocardial tissue Doppler imaging. Many articles had documented that peak velocity of early-diastolic trans-mitral inflow velocity divided by early-diastolic velocity over mitral annulus correlated closely to LVFP. However, myocardial tissue Doppler only provides the information of regional myocardium, so patients with regional wall motion abnormality, as coronary artery disease, can't be assessed by this method without handicap. In addition, conduction disturbance, like bundle branch block, also influences the result of myocardial tissue Doppler. For resolving those problems, the investigators had designed a new global parameter to assess LVFP. In the investigators prior study, left atrial distensibility correlated logarithmically to LVFP in patients with severe mitral regurgitation and also in patients with acute myocardial infarction. Left atrial distensibility provided a new viewpoint to assess left ventricular diastolic function and to predict prognosis. This time, to extend left atrial distensibility to general population received echocardiographic examination for predicting prognosis is attempted.

Condition or disease Intervention/treatment
Heart Failure Atrial Fibrillation Stroke Other: Echocardiography, including the measurements of left atrial (LA) distensibility

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Studies on Assessment of Left Atrial Distensibility to Predict Late Prognosis in Consecutive Patients Received Echocardiographic Examination
Study Start Date : July 2009
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Group/Cohort Intervention/treatment
Consecutive patients received echocardiographic examinations
Consecutive patients received echocardiography are willing to participate in this study.
Other: Echocardiography, including the measurements of left atrial (LA) distensibility
The LA volumes were measured at three points: 1) immediately before the mitral valve opening (maximal LV volume or Volmax); 2) at onset of the P-wave on electrocardiography (pre-atrial contraction volume or Volp); and 3) at mitral valve closure (minimal LV volume or Volmin). The LA distensibility was calculated as (Volmax - Volmin)x 100% / Volmin. The LA ejection fraction was calculated as (Volp - Volmin)x 100% / Volp. In all patients, LA volumes were indexed to body surface area (BSA).



Primary Outcome Measures :
  1. All cause mortality [ Time Frame: 2 years ]
    All cause mortality and heart failure with re-hospitalization were defined as hard cardiovascular event.

  2. Heart failure with hospitalization [ Time Frame: 2 years ]
    Heart failure with re-hospitalization is documented by at least one of the following: worse exercise tolerance and respiratory distress with NYHA class III or IV symptoms, presence of pulmonary rales, or chest radiography showing pulmonary congestion, which needs an augmented decongestive regimen with oral or intravenous medications during an in-hospital stay.


Secondary Outcome Measures :
  1. Atrial fibrillation [ Time Frame: 2 years ]
    Enrolled patients with intermittent tachycardia will receive Holter's EKG. Any events of atrial fibrillation documented by EKG or Holter, either paroxysmal or persistent, are accounted.

  2. Stroke [ Time Frame: 2 years ]
    Stroke is defined as a sudden onset of focal neurological deficit more than 24 hours and confirmed by brain computed tomography or magnetic resonance imaging. Trans-esophageal echocardiography is suggested to clarify whether cardiogenic or not for all patients with stroke.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients received echocardiographic examinations
Criteria

Inclusion Criteria:

  • consecutive patients received echocardiographic examination are willing to participate in this study.

Exclusion Criteria:

  • (1) patients with prosthetic mitral valves, or mitral stenosis
  • (2) rhythm other than sinus rhythm
  • (3) age less than 18 years-old
  • (4) inadequate image quality
  • (5) lack of informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01171040


Contacts
Contact: Jong-Khing Huang, MD 886-7-3422121 ext 1518 irb@vghks.gov.tw

Locations
Taiwan
Kaohsiung Veterans General Hospital Recruiting
Kaohsiung, Taiwan, 886
Contact: Jong-Khing Huang, MD    886-7-3422121 ext 1518    irb@vghks.gov.tw   
Contact: Shih-Hung Hsiao, MD    886-7-3422121 ext 2011    a841120@kimo.com   
Principal Investigator: Jong-Khing Huang, MD         
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Investigators
Principal Investigator: Shih-Hung Hsiao, MD Cardiovascular Center, Department of Internal Medicine, Kaohsiung Veterans General Hospital

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jong-Khing Huang, MD, Current Superintendent of Kaohsiung Veterans General Hospital, Kaohsiung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01171040     History of Changes
Other Study ID Numbers: VGHKS99-015
First Posted: July 28, 2010    Key Record Dates
Last Update Posted: March 8, 2011
Last Verified: July 2009

Keywords provided by Kaohsiung Veterans General Hospital.:
left atrial distensibility
mortality
heart failure
atrial fibrillation
stroke
prognosis

Additional relevant MeSH terms:
Heart Failure
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes