Echocardiographic Evaluation of Hypertensive Acute Pulmonary Edema

This study has been completed.
Sponsor:
Collaborator:
Ministry of Education and Research, Romania
Information provided by (Responsible Party):
Mircea Cinteza, Carol Davila University of Medicine and Pharmacy
ClinicalTrials.gov Identifier:
NCT00829855
First received: January 26, 2009
Last updated: March 4, 2013
Last verified: March 2013

January 26, 2009
March 4, 2013
May 2008
May 2009   (final data collection date for primary outcome measure)
acute myocardial dysfunction (systolic and diastolic) and/or dyssynchrony [ Time Frame: acute event and 48 to 96 h after the event ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00829855 on ClinicalTrials.gov Archive Site
  • surrogate markers of silent transient myocardial ischemia [ Time Frame: acute event and 48 to 96 h after the event ] [ Designated as safety issue: No ]
  • dynamic mitral regurgitation [ Time Frame: acute event and 48 to 96 h after the event ] [ Designated as safety issue: No ]
  • inter-ventricular interaction [ Time Frame: acute event and 48 to 96h after the event ] [ Designated as safety issue: No ]
Same as current
Not Provided
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Echocardiographic Evaluation of Hypertensive Acute Pulmonary Edema
Echocardiographic Evaluation of Hypertensive Acute Pulmonary Edema

Acute cardiogenic pulmonary edema (ACPE), one of the most severe forms of acute heart failure, represents 5% of hospital admissions. One of the most frequent phenomena encountered during ACPE is hypertensive crisis (hypertensive ACPE) but the mechanisms and causes of hypertensive ACPE are insufficiently understood. Few studies have evaluated the cardiac function during hypertensive ACPE, and these studies used only conventional echocardiography methods. New methods of evaluation of cardiac function in hypertensive ACPE (such as Tissue Doppler imaging) have not been used.

The objectives of this study are to evaluate presence and role of the following potential mechanisms of hypertensive ACPE: 1. acute myocardial dysfunction (systolic and diastolic); 2. silent transient myocardial ischemia; 3. acute mechanical left ventricular dyssynchrony; 4. dynamic mitral regurgitation; 5. inter-ventricular interaction. Conventional and Tissue Doppler echocardiography will be used to assess cardiac function.

Not Provided
Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
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Probability Sample

Patients admitted in the Cardiac Care Unit of an University and Emergency Hospital, with a diagnosis of acute cardiogenic pulmonary edema associated with hypertension (systolic blood pressure ≥160 mmHg)

  • Pulmonary Edema
  • Hypertension
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  • 1
    Patients with hypertensive (systolic blood pressure ≥160 mmHg) acute pulmonary edema, evaluated within 120 minutes after admittance.
  • 2
    The same patients from group 1 followed-up at 48 to 96 hours.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
May 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • acute onset of dyspnea within the preceding 8 hours
  • respiratory distress and pulmonary rales at any level
  • pulmonary congestion confirmed by chest radiography
  • systolic blood pressure > 160 mmHg before treatment
  • sinus rhythm
  • signed informed consent

Exclusion criteria:

  • acute myocardial infarction confirmed by myocardial necrosis markers (either CKMB or troponin I). Angina pectoris alone will not be excluded
  • significant left sided valvular disease (more than moderate). Mitral regurgitation of any severity will not be excluded, due to the hypothesis of the role of dynamic mitral regurgitation in the pathogenesis of acute hypertensive pulmonary edema
  • congenital heart disease
  • cardiac tamponade
  • rhythm and conduction disturbances that may have precipitated pulmonary edema, like sustained ventricular tachycardia and complete heart block
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Romania
 
NCT00829855
IDEI_242_2007, ID_216/PNII_242_2007
Yes
Mircea Cinteza, Carol Davila University of Medicine and Pharmacy
Carol Davila University of Medicine and Pharmacy
Ministry of Education and Research, Romania
Principal Investigator: Mircea Cinteza, MD, PhD University of Medicine and Pharmacy "Carol Davila" Bucharest
Principal Investigator: Dragos Vinereanu, MD, PhD University of Medicine and Pharmacy "Carol Davila" Bucharest
Study Chair: Andrei D Margulescu, MD University of Medicine and Pharmacy "Carol Davila" Bucharest
Carol Davila University of Medicine and Pharmacy
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP