NCT01168609

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
521

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2010

Completed
Last Updated

July 23, 2010

Status Verified

December 1, 2007

Enrollment Period

1.2 years

First QC Date

July 22, 2010

Last Update Submit

July 22, 2010

Conditions

Keywords

Left atrial distensibilityleft ventricular filling pressuretissue Dopplerprognosisacute myocardial infarction

Outcome Measures

Primary Outcomes (1)

  • in-hospital death after acute myocardial infarction

    All cause mortality during index hospitalization of acute myocardial infarction was recorded.

    Average 2 weeks

Secondary Outcomes (1)

  • 1-year hard event rate after acute myocardial infarction

    1 year after discharge

Study Arms (1)

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

Interventions

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.

patients with acute myocardial infarction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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. .

You may qualify if:

  • 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.

You may not qualify if:

  • \) presence of mitral stenosis or prosthetic mitral valves
  • \) more than mild severity of aortic/mitral valvular problem
  • \) any abnormality of atrial septum (e.g., atrial septal defect or aneurysm)
  • \) rhythm other than sinus rhythm
  • \) inadequate image quality
  • \) lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung, Taiwan, 886, Taiwan

Location

Related Publications (1)

  • Hsiao SH, Huang WC, Lin KL, Chiou KR, Kuo FY, Lin SK, Cheng CC. Left atrial distensibility and left ventricular filling pressure in acute versus chronic severe mitral regurgitation. Am J Cardiol. 2010 Mar 1;105(5):709-15. doi: 10.1016/j.amjcard.2009.10.052.

Related Links

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Jong-Khing Huang, MD

    Department of Medical Education and Research Kaohsiung Veterans General Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 22, 2010

First Posted

July 23, 2010

Study Start

December 1, 2007

Primary Completion

March 1, 2009

Study Completion

July 1, 2010

Last Updated

July 23, 2010

Record last verified: 2007-12

Locations