PhysioFlow to Detect Cardiotoxicity in Chemo

NCT ID: NCT02220569

Last Updated: 2015-09-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-07-31

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.

Conditions

Chemotherapy, Cancer, Cardiotoxicity, Physioflow

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Nathaniel Bouganim

Dr. Nathaniel Bouganim, Medical Oncologist at Royal Victoria Hospital muhc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nathaniel Bouganim, MD

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Locations

McGill university health center, Royal Victoria hospital

Montreal, Quebec, Canada

Site Status: NOT_YET_RECRUITING

Royal Victoria Hospital

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Ralph Maroun, M.D.

Role: CONTACT

ralph.maroun@mail.mcgill.ca

5147080701

Facility Contacts

Role: primary

ralph-maroun@hotmail.com

5147080701

Ralph Maroun

Role: backup

Ralph Maroun, MD

Role: primary

ralph-maroun@hotmail.com

5147080701

Other Identifiers

4073

Identifier Type: -

Identifier Source: org_study_id