Left Atrial Distensibility and Left Ventricular Filling Pressure in Acute Myocardial Infarction

This study has been completed.
Sponsor:
Collaborator:
No other funding source in this study
Information provided by:
Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier:
NCT01168609
First received: July 22, 2010
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

Left atrial volume (LAV) provides the significant prognostic information in the general population and patients with heart disease, including acute myocardial infarction, left ventricular dysfunction, mitral regurgitation, cardiomyopathy and atrial fibrillation. Large left atrial volume, which represents chronic diastolic dysfunction, is associated with poor outcome, regardless of systolic function. Thereby, LAV provides a long-term view of whether or not the patient has the disease of diastolic dysfunction, regardless of whatever loading conditions are present at the time of the examination, as the hemoglobin A1C in diabetes. However, whether left atrial (LA) parameters could correlate with LVFP and reflect short-term change in left ventricular filling pressure(LVFP) remains unknown. Only one article of our team confirmed the relationship between LAV and LVFP in patients with severe mitral regurgitation by simultaneous echocardiography-catheterization. The prior report proposed a new parameter, LA distensibility, and disclosed its logarithmic relationship with LVFP. The LA distensibility precisely indicated rapid change in LVFP of patients with acute severe mitral regurgitation, and was even superior to mitral E/Em (early-diastolic mitral inflow velocity divided by early-diastolic mitral annular velocity). As left atrial pressure rises to maintain adequate left ventricular diastolic filling, increased atrial wall tension tends to dilate the chamber and stretch the atrial myocardium. Therefore, the smaller left atrial stretchability, the more pressure left atrium (LA) faces to. The first objective of this study was to test the value of LA distensibility for assessing LVFP, particularly in patients with acute myocardial infarction. The second objective was to assess the prognostic value of LA distensibility.


Condition Intervention
Myocardial Infarction
Procedure: Primary percutaneous coronary intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Usefulness of Left Atrial Distensibility to Assess Left Ventricular Filling Pressure and to Predict Prognosis in Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Kaohsiung Veterans General Hospital.:

Primary Outcome Measures:
  • in-hospital death after acute myocardial infarction [ Time Frame: Average 2 weeks ] [ Designated as safety issue: No ]
    All cause mortality during index hospitalization of acute myocardial infarction was recorded.


Secondary Outcome Measures:
  • 1-year hard event rate after acute myocardial infarction [ Time Frame: 1 year after discharge ] [ Designated as safety issue: No ]
    After index hospitalization, patients were followed up at our cardiovascular clinic for at least 1 year. A follow-up survey assessing hard cardiovascular (CV) events was carried out after discharge. All cause mortality and heart failure with re-hospitalization were defined as hard CV event. Follow-up was performed between December 2007 and February 2010 by telephone interviews, medical record reviews, and home visits.


Enrollment: 521
Study Start Date: December 2007
Study Completion Date: July 2010
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
patients with acute myocardial infarction
Acute myocardial infarction (AMI) was defined using the European Society of Cardiology / American College of Cardiology guidelines. Myocardial infarction was detected by the presence of at least two of the following criteria: chest pain lasting more than 30 minutes, typical electrocardiographic changes, and elevated creatinine kinase-MB fraction. Consecutive patients 18 years of age or older who presented within 12 hours after the onset of symptoms were considered for enrollment. Patients who had ST-segment elevation of 1 mm or more in two or more contiguous leads were classified as ST-segment elevation MI.
Procedure: Primary percutaneous coronary intervention
Primary percutaneous coronary intervention (PCI) and stenting were performed for just the culprit lesion using standard techniques and bare-metal stents in all patients. Unfractionated heparin was used for 3 days after PCI, except in some cases with contraindications, and the dose of unfractionated heparin was selected to prolong the activated partial thromboplastin time by 2-3 times. The decision to use glycoprotein IIb/IIIa inhibitors was left to the discretion of the treating physician. The measurements of LVFP were performed via a fluid-filled pig-tail catheter placed into the LV after coronary angiography if PCI was not indicated or after primary PCI.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Between December 2007 and March 2009, this study enrolled AMI patients who had received cardiac catheterization for potential percutaneous coronary intervention (PCI). Myocardial infarction was detected by the presence of at least two of the following criteria: chest pain lasting more than 30 minutes, typical electrocardiographic changes, and elevated creatinine kinase-MB fraction. Consecutive patients 18 years of age or older who presented within 12 hours after the onset of symptoms were considered for enrollment. Patients who had ST-segment elevation of 1 mm or more in two or more contiguous leads were classified as ST-segment elevation MI. Others were classified as non ST-segment elevation MI. .

Criteria

Inclusion Criteria:

  • Myocardial infarction was detected by the presence of at least two of the following criteria: chest pain lasting more than 30 minutes, typical electrocardiographic changes, and elevated creatinine kinase-MB fraction. Consecutive patients 18 years of age or older who presented within 12 hours after the onset of acute myocardial infarction were considered for enrollment.

Exclusion Criteria:

  • 1) presence of mitral stenosis or prosthetic mitral valves
  • 2) more than mild severity of aortic/mitral valvular problem
  • 3) any abnormality of atrial septum (e.g., atrial septal defect or aneurysm)
  • 4) rhythm other than sinus rhythm
  • 5) inadequate image quality
  • 6) lack of informed consent
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01168609

Locations
Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 886
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
No other funding source in this study
Investigators
Study Chair: Jong-Khing Huang, MD Department of Medical Education and Research Kaohsiung Veterans General Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Jong-Khing Huang, MD, Current Superintendent of Kaohsiung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01168609     History of Changes
Other Study ID Numbers: VGHKS97-CT4-17
Study First Received: July 22, 2010
Last Updated: July 22, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by Kaohsiung Veterans General Hospital.:
Left atrial distensibility
left ventricular filling pressure
tissue Doppler
prognosis
acute myocardial infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 27, 2014