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PhysioFlow to Detect Cardiotoxicity in Chemo (PULSE-ECCho)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Chemotherapy, Cancer, Cardiotoxicity, Physioflow

Detailed Description:

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 Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. comparing the change in ejection fraction measured by physioflow and MUGA scan [ Time Frame: at initial diagnosis and after 3 month ]

Secondary Outcome Measures :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients presenting to the oncology day clinic at Royal Victoria hospital and receiving chemotherapy.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

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


Contacts
Contact: Ralph Maroun, M.D. 5147080701 ralph.maroun@mail.mcgill.ca

Locations
Canada, Quebec
McGill university health center, Royal Victoria hospital Not yet recruiting
Montreal, Quebec, Canada, h3a 1a1
Contact    5147080701    ralph-maroun@hotmail.com   
Contact: Ralph Maroun         
Principal Investigator: Nathaniel Bouganim, M.D.         
Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, h4a 1v3
Contact: Ralph Maroun, MD    5147080701    ralph-maroun@hotmail.com   
Principal Investigator: Nathaniel Bouganim, MD         
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Nathaniel Bouganim, MD McGill University Health Center
More Information

Responsible Party: Nathaniel Bouganim, Dr. Nathaniel Bouganim, Medical Oncologist at Royal Victoria Hospital muhc, McGill University Health Center
ClinicalTrials.gov Identifier: NCT02220569     History of Changes
Other Study ID Numbers: 4073
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Cardiotoxicity
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries