Recruiting

Strain Echo

Sponsor:

Wayne State University

Code:

NCT02371642

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The purpose of this project is to evaluate the utility of left ventricular strain as part of the assessment of patients in the emergency department with acute heart failure (HF). The central hypothesis of the investigation is that left ventricular strain will prove to be a treatment response variable in patients with acute HF. Patients who are being treated for acute HF with intravenous (IV) vasoactive medications (diuretics, vasodilators, inotropes) will be eligible for enrollment. Patients who give written consent will receive a focused bedside echocardiogram within 30 minutes of the initiation of therapy for acute HF. Images that are captured during this echocardiogram will be interpreted by a blinded cardiologist offline. 23 hours after this initial focused echocardiogram a member of the study team will perform a follow-up focused echocardiogram, capturing the same images that will then be interpreted by a blinded cardiologist offline.

Offline analysis will be performed using a proprietary software package from General Electric called Automated Function Imaging (AFI). The AFI software will be used to calculate longitudinal strain of the left ventricle (LV). Regional and global strain values will be calculated for each focused echocardiogram for each subject. It is our hypothesis that LV strain will demonstrate improvements from the initial echocardiogram to the follow-up echocardiogram, unlike other echocardiographic indices in HF such as LV ejection fraction.

Conditions

Heart Failure

Study ID

NCT02371642

Start date

Jan, 2015

Status verified date

Oct, 2016

Primary completion date

Jan, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 years of age or greater
  • Ability for the patient to provide written informed consent
  • Planned treatment with intravenous (IV) medications (diuretics, vasodilators, inotropes) for acute HF

Exclusion Criteria:

  • Need for emergent, resuscitative intervention (e.g., cardiopulmonary resuscitation, endotracheal intubation)
  • Rapid atrial fibrillation or other arrhythmia that requires IV rate or rhythm control
  • Plans for emergent percutaneous coronary intervention (PCI) from the ED
  • Pregnancy
  • Incarceration
  • history of cardiac transplant
  • planned transfer to another institution

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • change in global longitudinal strain (GLS) [ Time Frame: 23 hours ]

Central Contacts and Locations

Central contacts

Locations

Detroit Receiving Hospital

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Principal Investigator:

Mark J Favot, M.D.

More Information

Sponsor

Wayne State University

Last update posted

Nov 1, 2016

Last verified

Oct, 2016

Keywords

  • Echocardiography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wayne State University on 2016-11-01.