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Sponsors and Collaborators: |
Carol Davila University of Medicine and Pharmacy Ministry of Education and Research, Romania |
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Information provided by: | Carol Davila University of Medicine and Pharmacy |
ClinicalTrials.gov Identifier: | NCT00829855 |
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.
Condition |
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Pulmonary Edema Hypertension |
Study Type: | Observational |
Study Design: | Case-Crossover, Prospective |
Official Title: | Echocardiographic Evaluation of Hypertensive Acute Pulmonary Edema |
Estimated Enrollment: | 40 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
Patients with hypertensive (systolic blood pressure ≥160 mmHg) acute pulmonary edema, evaluated within 120 minutes after admittance.
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2
The same patients from group 1 followed-up at 48 to 96 hours.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | 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)
Inclusion Criteria:
Exclusion criteria:
Contact: Andrei D Margulescu, MD | 004021 3180576 | andrei_marg@yahoo.com |
Contact: Dragos Vinereanu, MD, PhD | 004021 3180576 | dvinereanu@yahoo.com |
Romania | |
Department of Cardiology, University and Emergency Hospital of Bucharest | Recruiting |
Bucharest, Romania, 050098 | |
Principal Investigator: Mircea Cinteza, MD, PhD | |
Principal Investigator: Dragos Vinereanu, MD, PhD | |
Sub-Investigator: Andrei D Margulescu, MD | |
Sub-Investigator: Roxana C Sisu, MD | |
Sub-Investigator: Maria Florescu, MD |
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 |
Responsible Party: | University of Medicine and Pharmacy "Carol Davila" Bucharest ( Professor Mircea Cinteza, MD, PhD ) |
Study ID Numbers: | IDEI_242_2007, ID_216/PNII_242_2007 |
Study First Received: | January 26, 2009 |
Last Updated: | January 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00829855 History of Changes |
Health Authority: | Romania: National Authority for Scientific Research |
pulmonary edema hypertension echocardiography |
Signs and Symptoms Pulmonary Edema Respiratory Tract Diseases Lung Diseases |
Vascular Diseases Edema Hypertension |
Signs and Symptoms Pulmonary Edema Respiratory Tract Diseases Lung Diseases |
Vascular Diseases Edema Cardiovascular Diseases Hypertension |