Radiofrequency-based Speckle Tracking Echocardiography to Evaluate Diastolic Function (RF-SPEED)

University of Michigan

Status and phase: Completed; Phase 2; Phase 1

Conditions: Heart Failure, Diastolic

Treatments: Device: Diastolic function assessment; Device: Echocardiography machine GE Vivid E9; Device: Echocardiography system Ultra DCI Model 5000

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT01182805

5R44HL071379 (U.S. NIH Grant/Contract)

RF-SPEED

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Single arm study.

Other group

Treatment:

Device: Diastolic function assessment

Device: Echocardiography machine GE Vivid E9

Device: Echocardiography system Ultra DCI Model 5000