Chemotherapy, Cancer, Cardiotoxicity, PhysioflowPULSE-ECChoNCT02220569
PhysioFlow to Detect Cardiotoxicity in Chemo
An observational study of Chemotherapy, Cancer, Cardiotoxicity, Physioflow, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy, Cancer, Cardiotoxicity, Physioflow
- How many people
- 100 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2014to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients presenting to the oncology day clinic at Royal Victoria hospital and receiving chemotherapy.
Who may be able to join
- Age above 18 years old
- Histologically confirmed diagnosis of cancer
- ECOG 0 to 2
- Provide written consent after the investigational nature, study design, risks and benefits of the study have been explained
- Able to adhere to the study visit schedule and other protocol requirements
- Control Group
Show all 12Show fewer
- Age above 18 years old
- No previous history of cancer
- ECOG 0 to 2
- Did not receive chemotherapeutic agents (even if outside the context of cancer)
- Provide written consent after the investigational nature, study design, risks and benefits of the study have been explained
- Able to adhere to the study visit schedule and other protocol requirements
Who cannot join
- Age less than 18 years
- ECOG 3-4
- Suspected or proven severe aortic insufficiency
- Patient under cardiopulmonary bypass assistance (I.e.: Left ventricular assisting device)
- Congenital cardiac deformities ,such as septal defects
- Refuse to comply with the specified visit schedules and requirements
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Not yet recruiting
McGill university health center, Royal Victoria hospital
Montreal, Quebec, h3a 1a1
5147080701, ralph-maroun@hotmail.com
Ralph Maroun
- Recruiting
Royal Victoria Hospital
Montreal, Quebec, h4a 1v3
Ralph Maroun, MD, 5147080701, ralph-maroun@hotmail.com
Nathaniel Bouganim, MD
About this study
Official title: PhysioFlow Use in Longterm Screening and Evaluation of Cardiotoxicity in Chemotherapy
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.
Read the 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.
- Medical subject headings
- Neoplasms, Cardiotoxicity
What is being measured
The primary outcome is the main question the study is designed to answer.
comparing the change in ejection fraction measured by physioflow and MUGA scan
Measured: at initial diagnosis and after 3 month
Secondary outcomes (1)
acceptance score on the five-point Likert Scale to measure tolerability
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
Measured: up to 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy, Cancer, Cardiotoxicity, PhysioflowStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathaniel Bouganim, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Nathaniel Bouganim, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220569
- Sponsor's protocol ID
- 4073
- Acronym
- PULSE-ECCho
- Status last verified
- Sep 2015
- First submitted
- 14 Aug 2014
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PhysioFlow Use in Longterm Screening and Evaluation of Cardiotoxicity in Chemotherapy
- ClinicalTrials.gov ID
- NCT02220569
- Acronym / sponsor ID
- PULSE-ECCho / 4073
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 20 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presenting to the oncology day clinic at Royal Victoria hospital and receiving chemotherapy.
Key inclusion criteria (12 listed)
- Age above 18 years old
- Histologically confirmed diagnosis of cancer
- ECOG 0 to 2
- Provide written consent after the investigational nature, study design, risks and benefits of the study have been explained
- Able to adhere to the study visit schedule and other protocol requirements
Key exclusion criteria (6 listed)
- Age less than 18 years
- ECOG 3-4
- Suspected or proven severe aortic insufficiency
- Patient under cardiopulmonary bypass assistance (I.e.: Left ventricular assisting device)
- Congenital cardiac deformities ,such as septal defects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
comparing the change in ejection fraction measured by physioflow and MUGA scan
Time frame: at initial diagnosis and after 3 month
1 secondary outcome
acceptance score on the five-point Likert Scale to measure tolerability
Time frame: up to 24 hrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathaniel Bouganim, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy, Cancer, Cardiotoxicity, Physioflow, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ralph Maroun, M.D. (5147080701, ralph.maroun@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparing the change in ejection fraction measured by physioflow and MUGA scan (time frame: at initial diagnosis and after 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.