Phase 2
N=50
Radiofrequency-based Speckle Tracking Echocardiography to Evaluate Diastolic Function
Heart Failure, Diastolic
Bottom Line
View on ClinicalTrials.gov: NCT01182805 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: Diastolic Circumferential Strain Rate During Isovolumic Relaxation — 0.61; 0.37; 0.34 1/sec
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Echocardiography system Ultra DCI Model 5000 (Device); Echocardiography machine GE Vivid E9 (Device); Diastolic function assessment (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diastolic Circumferential Strain Rate During Isovolumic Relaxation |
0.61; 0.37; 0.34 | — |
| PRIMARY Early Diastolic Mitral Annular Velocity (E-prime) Using Tissue Doppler |
8.1; 5.6; 7.0 | — |
Summary
The purpose of this study is to evaluate a novel ultrasound system's ability to assess the relaxing properties of the heart compared to current techniques.
Eligibility Criteria
Inclusion Criteria
- Patients scheduled to undergo a clinically indicated left heart cardiac catheterization will be recruited for the study.
Exclusion Criteria
- Suspected acute ST elevation myocardial infarction.
- Acute coronary syndrome with active ongoing chest pain
- Known or suspected acute aortic dissection
- Known or suspected cardiac tamponade
- Known history of unoperated constrictive pericarditis
- Known or suspected severe aortic stenosis or severe mitral regurgitation
- Heart rhythm other than sinus rhythm on pre-cath EKG
- Age < 18 years old
- Unable to provide informed consent
Data sourced from ClinicalTrials.gov (NCT01182805). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.