Recruiting

PhysioFlow

Sponsor:

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

Code:

NCT02220569

Conditions

Chemotherapy, Cancer, Cardiotoxicity, Physioflow

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Chemotherapy, Cancer, Cardiotoxicity, Physioflow

Study ID

NCT02220569

Start date

Oct, 2014

Status verified date

Sep, 2015

Completion date

Jul, 2016

Anticipated

Primary completion date

Jul, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • comparing the change in ejection fraction measured by physioflow and MUGA scan [ Time Frame: at initial diagnosis and after 3 month ]

Central Contacts and Locations

Central contacts

Ralph Maroun, M.D.

5147080701ralph.maroun@mail.mcgill.ca

Locations

Royal Victoria Hospital

Recruiting

Montreal, Quebec, Canada, h4a 1v3

Contacts

Ralph Maroun, MD

5147080701ralph-maroun@hotmail.com

Principal Investigator:

Nathaniel Bouganim, MD

More Information

Sponsor

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

Last update posted

Sep 23, 2015

Last verified

Sep, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2015-09-23.