Echocardiographic Evaluation of Hypertensive Acute Pulmon... | NCT00829855

Studies
Echocardiographic Evaluation of Hypertensive Acute Pulmonary Edema

NCT00829855

Sponsor

Carol Davila University of Medicine and Pharmacy

Status

Completed

Last Update Posted

Mar 5, 2013Estimated

Enrollment

51Actual

Phase

Not provided

Conditions

Pulmonary Edema
Hypertension

Interventions

Not provided

Countries

Romania

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
ID_216/PNII_242_2007

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Jan 26, 2009

First Submission Date that Met QC Criteria

Jan 26, 2009

First Posted Date

Jan 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2013

Last Update Posted Date

Mar 5, 2013Estimated

Name	Class
Ministry of Education, Research, Youth and Sport, Romania	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
acute myocardial dysfunction (systolic and diastolic) and/or dyssynchrony		acute event and 48 to 96 h after the event

Secondary Outcomes

Measure	Description	Time Frame
surrogate markers of silent transient myocardial ischemia		acute event and 48 to 96 h after the event
dynamic mitral regurgitation		acute event and 48 to 96 h after the event

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Principal Investigator
Andrei D Margulescu, MD	University of Medicine and Pharmacy "Carol Davila" Bucharest	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Cardiology, University and Emergency Hospital of Bucharest		Bucharest		050098	Romania

Condition Browse Module

MeSH Terms

ID	Term
D011654	Pulmonary Edema
D006973	Hypertension

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided