Left Atrial Distensibility to Predict Prognosis in Consecutive Patients
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Purpose
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 | Intervention |
|---|---|
|
Heart Failure Atrial Fibrillation Stroke |
Other: Echocardiography, including the measurements of left atrial (LA) distensibility |
| Study Type: | Observational |
| Study Design: | 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 |
- All cause mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]All cause mortality and heart failure with re-hospitalization were defined as hard cardiovascular event.
- Heart failure with hospitalization [ Time Frame: 2 years ] [ Designated as safety issue: No ]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.
- Atrial fibrillation [ Time Frame: 2 years ] [ Designated as safety issue: No ]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.
- Stroke [ Time Frame: 2 years ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 2000 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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).
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Consecutive patients received echocardiographic examinations
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
Contacts and Locations| Contact: Jong-Khing Huang, MD | 886-7-3422121 ext 1518 | irb@vghks.gov.tw |
| 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 | |
| Principal Investigator: | Shih-Hung Hsiao, MD | Cardiovascular Center, Department of Internal Medicine, Kaohsiung Veterans General Hospital |
More Information
Additional Information:
Publications:
| 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 |
| Study First Received: | July 23, 2010 |
| Last Updated: | March 7, 2011 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by Kaohsiung Veterans General Hospital.:
|
left atrial distensibility mortality heart failure |
atrial fibrillation stroke prognosis |
Additional relevant MeSH terms:
|
Atrial Fibrillation Heart Failure Stroke Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases |
Pathologic Processes Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013