Clinical trial NCT02220569: PhysioFlow to Detect Cardiotoxicity in Chemo
Official title: PhysioFlow Use in Longterm Screening and Evaluation of Cardiotoxicity in Chemotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chemotherapy, Cancer, Cardiotoxicity, Physioflow
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2014-08-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting to the oncology day clinic at Royal Victoria hospital and receiving chemotherapy.

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.

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.

Eligibility 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

Primary outcomes:
measure: comparing the change in ejection fraction measured by physioflow and MUGA scan
timeFrame: at initial diagnosis and after 3 month
Secondary outcomes:
measure: acceptance score on the five-point Likert Scale to measure tolerability
timeFrame: up to 24 hrs
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill university health center, Royal Victoria hospital
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Nathaniel Bouganim, MD
role: PRINCIPAL_INVESTIGATOR
References: