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| Name | Class |
|---|---|
| St. Olavs Hospital | OTHER |
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TRUST-ACE will compare a simplified echocardiographic protocol focusing on ventricular function with the guideline recommended comprehensive echocardiographic examination using a randomised design in follow-up of breast-cancer patients with respect to identification of cancer treatment related cardiac dysfunction (CTRCD).
Secondly, the study will evaluate whether novel tools used to improve standardization of recordings as well as automated measurements of central measurements, e.g. ejection fraction (EF) and global longitudinal strain (GLS) can improve the precision of echocardiography in daily clinical practice.
Cancer treatment related cardiac dysfunction (CTRCD) is a well-known complication to cancer treatment with implication both with respect to treatment and prognosis of the cancer as well as heart.
CTRCD, often named cardiotoxicity, usually refers to myocardial dysfunction and heart failure developing after administration of potentially cardiotoxic therapy. By precise diagnostics, adequate treatment can be started early to prevent heart failure and unnecessary discontinuation of the potential life-saving cancer treatment may be avoided. However, guideline advocated analyses of cardiac function (EF and GLS) by echocardiography are time consuming and many operators base their semi-quantitative estimates on visual assessment. Furthermore, test-retest variability for both EF and GLS are significant and may exceed the guideline recommended cut-offs for identification of cancer therapy-related cardiovascular toxicity.
The study will compare a simplified echocardiographic protocol focusing on ventricular function with the guideline recommended comprehensive echocardiographic examination using a randomized design. The study will also evaluate if novel tools for improved standardization of recordings and automated measurements of relevant measurements as ejection fraction (EF) and global longitudinal strain (GLS) can improve the diagnostic precision.
Breast cancer patients referred for follow-up at the echocardiography will be included.
Patients will be randomized 1:1 to A) examinations with two- and three-dimensional echocardiography including all central measures of cardiac size and function measured by sonographers as recommended by the European guidelines and as clinical practice or B) echocardiographic examinations focusing on the ventricles.
Subpopulations will undergo additional testing with serial echocardiographic examinations by four operators on the same day with and without use of novel tools for improved standardization of recordings and automated measurements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | Active Comparator | Standard of care echocardiographic follow-up |
|
| Simplified care | Experimental | Simplified echocardiographic follow-up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive echocardiographic follow-up | Diagnostic Test | Comprehensive echocardiographic follow-up for identification of CRTCD in breast cancer patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients correctly classified with cancer therapy related cardiac dysfunction (CTRCD) | Cancer treatment related cardiac dysfunction | 15 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients misclassified as having/not having cancer therapy related cardiac dysfunction (CTRCD) | Proportion of misclassified CTRCD | 15 months |
| Risk classification | Risk classification for identification of CTRCD |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Espen Holte, MD. PhD | Contact | 92243119 | 47 | espen.holte@stolav.no |
| Havard Dalen, MD, PhD | Contact | 95871716 | 47 | havard.dalen@ntnu.no |
| Name | Affiliation | Role |
|---|---|---|
| Espen Holte, MD, PhD | St. Olavs Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Olavs hospital | Recruiting | Trondheim | 7491 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40747448 | Derived | Sabo S, Pettersen H, Boen GC, Jakobsen EO, Langoy PK, Nilsen HO, Pasdeloup D, Smistad E, Ostvik A, Lovstakken L, Stolen S, Grenne B, Dalen H, Holte E. Real-time guidance and automated measurements using deep learning to improve echocardiographic assessment of left ventricular size and function. Eur Heart J Imaging Methods Pract. 2025 Jul 21;3(2):qyaf094. doi: 10.1093/ehjimp/qyaf094. eCollection 2025 Jul. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D066126 | Cardiotoxicity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Randomization 1:1 to two different modes of follow-up
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No masking
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| Simplified echocardiographic follow-up | Diagnostic Test | Simplified echocardiographic follow-up for identification of CRTCD in breast cancer patients |
|
| 0 days |
| Risk classification | Risk classification for identification of CTRCD | 15 months |
| Test-retest variability, systolic left ventricular size and function | Test-retest variability of systolic left ventricular size and function | 0 days |
| Test-retest variability, systolic left ventricular size and function | Test-retest variability systolic left ventricular size and function | 15 months |
| Test-retest variability, diastolic left ventricular size and function | Test-retest variability of diastolic left ventricular function | 0 days |
| Test-retest variability, diastolic left ventricular size and function | Test-retest variability of diastolic left ventricular size and function | 15 months |
| Test-retest variability, right ventricular size and function | Test-retest variability of right ventricular size and function | 0 days |
| Test-retest variability, right ventricular size and function | Test-retest variability of right ventricular size and function | 15 months |
| Time consumption | Time used for echocardiographic examination | 0 days |
| Time consumption | Time used for echocardiographic examination | 15 days |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |