Clinical trial · Observational
PhysioFlow to Detect Cardiotoxicity in Chemo
PhysioFlow Use in Longterm Screening and Evaluation of Cardiotoxicity in Chemotherapy
NCT02220569CI-TRIAL-00019185PULSE-ECChounknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
PULSE-ECCho will focus on trying to detect cardiotoxicity in cancer patients receiving chemotherapy early on in order to avoid irreversible damage. In addition to that, we will test if the PhysioFlow is non-inferior to the conventional MUGA scan.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy, Cancer, Cardiotoxicity, Physioflow | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- comparing the change in ejection fraction measured by physioflow and MUGA scan
- timeFrame
- at initial diagnosis and after 3 month
Secondary outcomes (1)
- measure
- acceptance score on the five-point Likert Scale to measure tolerability
- timeFrame
- up to 24 hrs
- description
- At the end of physioflow and or MUGA scan, a questionnaire to assess acceptance was proposed to all patients. The following aspects were evaluated: preparation and information before the imaging examination, degree of preceding concern, comfort, helplessness during the examination, pain experienced, degree of overall satisfaction. Evaluation was performed with a five-point qualitative Likert scale: very low, low, moderate, high, very high
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age above 18 years old 2. Histologically confirmed diagnosis of cancer 3. ECOG 0 to 2 4. Provide written consent after the investigational nature, study design, risks and benefits of the study have been explained 5. Able to adhere to the study visit schedule and other protocol requirements Control Group 1. Age above 18 years old 2. No previous history of cancer 3. ECOG 0 to 2 4. Did not receive chemotherapeutic agents (even if outside the context of cancer) 5. Provide written consent after the investigational nature, study design, risks and benefits of the study have been explained 6. Able to adhere to the study visit schedule and other protocol requirements Exclusion Criteria: 1. Age less than 18 years 2. ECOG 3-4 3. Suspected or proven severe aortic insufficiency 4. Patient under cardiopulmonary bypass assistance (I.e.: Left ventricular assisting device) 5. Congenital cardiac deformities ,such as septal defects 6. Refuse to comply with the specified visit schedules and requirements
References
Publications (0)
Data not yet available
No reference posted for this study.