PhysioFlow to Detect Cardiotoxicity in Chemo

Chemotherapy, Cancer, Cardiotoxicity, Physioflow Clinical Trial

— PULSE-ECCho  

Official title:

PhysioFlow Use in Longterm Screening and Evaluation of Cardiotoxicity in Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02220569
• Other study ID #: 4073
• Status: Recruiting
• Phase: N/A
• First received: August 14, 2014
• Last updated: September 21, 2015
• Start date: October 2014
• Est. completion date: July 2016

Study information

• Verified date: September 2015
• Source: McGill University Health Center
• Contact: Ralph Maroun, M.D.
• Phone: 5147080701
• Email: ralph.maroun[@]mail.mcgill.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Health Canada
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chemotherapy, Cancer, Cardiotoxicity, Physioflow

Locations

Country	Name	City	State
Canada	McGill university health center, Royal Victoria hospital	Montreal	Quebec
Canada	Royal Victoria Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparing the change in ejection fraction measured by physioflow and MUGA scan		at initial diagnosis and after 3 month	No
Secondary	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	up to 24 hrs	No