Deep Learning-Based Automated Pressure-Strain Loop Analysis
Noninvasive left ventricular pressure-strain loop analysis estimates myocardial work from longitudinal strain, brachial systolic blood pressure, and cardiac valve-event timing. It provides global work index, constructive work, wasted work, and work efficiency.
This study evaluates a deep-learning method that automates myocardial work and loop-shape analysis. The method may reduce analysis time, improve reproducibility, and identify patterns associated with heart failure.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Håvard Dalen, Professor Havard Dalen, MD, Ph
- Phone Number: +4772828027
- Email: havard.dalen@ntnu.no
Study Locations
-
-
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Trondheim, Norway, 7006
- St. Olavs hospital
-
Contact:
- Ingrid Yttervoll, MD
- Phone Number: 90741665
- Email: ingrid.yttervoll@ntnu.no
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Heart failure participants:
- Age ≥18 years
- Able to provide informed consent
- Previous myocardial infarction
- Left ventricular ejection fraction ≤40% after myocardial infarction
Healthy volunteers:
- Age ≥18 years
- Able to provide informed consent
Exclusion Criteria:
Heart failure participants:
- Unstable disease
- Contraindication to exercise testing or echocardiography, as judged by an experienced cardiologist
Healthy volunteers:
- Hypertension
- Diabetes mellitus
- Dyslipidemia
- Current smoking
- Pregnancy
- Significant systemic disease
- Cardioactive medication affecting heart rate, myocardial contractility, or vascular tone
- Echocardiographic findings suggesting structural heart disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Participants With Heart Failure
Participants undergo echocardiography at rest, during sustained handgrip, and during semi-supine bicycle exercise. |
Participants perform sustained isometric handgrip at around 30 % of maximal voluntary contraction for 5 minutes during echocardiography. Participants perform graded semi-supine bicycle exercise during echocardiography. |
|
Experimental: Healthy Volunteers
Healthy volunteers undergo echocardiography at rest, during sustained handgrip, and during semi-supine bicycle exercise. |
Participants perform sustained isometric handgrip at around 30 % of maximal voluntary contraction for 5 minutes during echocardiography. Participants perform graded semi-supine bicycle exercise during echocardiography. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Echocardiographic Acquisition Success
Time Frame: During one study visit: at rest, during the handgrip and bicycle test.
|
Percentage of acquired examinations successfully processed by the deep-learning pipeline to generate myocardial work indices, assessed separately at rest, during handgrip, and during bicycle exercise. |
During one study visit: at rest, during the handgrip and bicycle test.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Agreement Between Deep Learning- and Expert-Derived Myocardial Work Indices
Time Frame: Echocardiograms acquired at rest and during handgrip and bicycle exercise at a single study visit.
|
Agreement for myocardial work indices will be assessed using mean bias with 95% limits of agreement, and mean absolute error. |
Echocardiograms acquired at rest and during handgrip and bicycle exercise at a single study visit.
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/1059_1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Individual participant data sharing is not currently planned. Any future sharing would require appropriate ethical, institutional, and data-protection approvals.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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