PhysioFlow to Detect Cardiotoxicity in Chemo (PULSE-ECCho)
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|ClinicalTrials.gov Identifier: NCT02220569|
Recruitment Status : Unknown
Verified September 2015 by Nathaniel Bouganim, McGill University Health Center.
Recruitment status was: Recruiting
First Posted : August 20, 2014
Last Update Posted : September 23, 2015
|Condition or disease|
|Chemotherapy, Cancer, Cardiotoxicity, Physioflow|
Our objective is to compare the PhysioFlow to the MUGA scan and see if the results are statistically the same using both techniques. This is what is known as a non-inferior study. The advantage of PhysioFlow is that it is non-invasive, fast and it is done at the bedside or while the patient is receiving his or her chemotherapy.
The patient will be tested with the MUGA scan, as per the standard of care, before chemotherapy is initiated and at every 3 months. The patient will also be tested with the PhysioFlow at the same dates of the MUGA scan. In addition to that, the patients will be tested at each chemotherapy cycle with the PhysioFlow.
Should the PhysioFlow indicate the patient has a cardiac toxicity as the patient is receiving chemotherapy, the results will be confirmed with the MUGA scan.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||PhysioFlow Use in Longterm Screening and Evaluation of Cardiotoxicity in Chemotherapy|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||July 2016|
- comparing the change in ejection fraction measured by physioflow and MUGA scan [ Time Frame: at initial diagnosis and after 3 month ]
- acceptance score on the five-point Likert Scale to measure tolerability [ Time Frame: up to 24 hrs ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220569
|Contact: Ralph Maroun, M.D.||firstname.lastname@example.org|
|McGill university health center, Royal Victoria hospital||Not yet recruiting|
|Montreal, Quebec, Canada, h3a 1a1|
|Contact 5147080701 email@example.com|
|Contact: Ralph Maroun|
|Principal Investigator: Nathaniel Bouganim, M.D.|
|Royal Victoria Hospital||Recruiting|
|Montreal, Quebec, Canada, h4a 1v3|
|Contact: Ralph Maroun, MD 5147080701 firstname.lastname@example.org|
|Principal Investigator: Nathaniel Bouganim, MD|
|Principal Investigator:||Nathaniel Bouganim, MD||McGill University Health Center|