PhysioFlow to Detect Cardiotoxicity in Chemo (PULSE-ECCho)

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.

Study Overview

• Status: Unknown
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Ralph Maroun, M.D.; Phone Number: 5147080701; Email: ralph.maroun@mail.mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, h3a 1a1
      • Not yet recruiting
      • McGill University Health Center, Royal Victoria Hospital
      • Contact: Phone Number: 5147080701; Email: ralph-maroun@hotmail.com
      • Contact: Ralph Maroun
      • Principal Investigator: Nathaniel Bouganim, M.D.
    • Montreal, Quebec, Canada, h4a 1v3
      • Recruiting
      • Royal Victoria Hospital
      • Contact: Ralph Maroun, MD; Phone Number: 5147080701; Email: ralph-maroun@hotmail.com
      • Principal Investigator: Nathaniel Bouganim, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients presenting to the oncology day clinic at Royal Victoria hospital and receiving chemotherapy.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
comparing the change in ejection fraction measured by physioflow and MUGA scan	at initial diagnosis and after 3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Investigators: Principal Investigator: Nathaniel Bouganim, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): July 1, 2016
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: August 14, 2014
• First Submitted That Met QC Criteria: August 18, 2014
• First Posted (Estimate): August 20, 2014

Study Record Updates

• Last Update Posted (Estimate): September 23, 2015
• Last Update Submitted That Met QC Criteria: September 21, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Wounds and Injuries; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Cardiotoxicity
• Other Study ID Numbers: 4073