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Clinical Trials in Canada / NCT04541212
Active, not recruiting Observational

Identification and Evaluation of Patients at Risk of Developing Cardiotoxicity After Receiving Chemotherapy for Breast Cancer, Lymphoma or Leukemia

NCT04541212 · tracked via the Priya Life Science Canada tracker
Sponsor
Montreal Heart Institute
Phase
Observational
Started
2021-12-02
Last updated
2026-10-08

Condition(s) studied

Breast CancerLymphomaLeukemia

Investigational drug(s) / intervention(s)

Cardiac ImagingData Collection

Cardiac Imaging: Cardiac Imaging: echography, ECG, MRI Blood tests: Lipid profile, hs-CRP, metabolic markers, HDL functionality, pharmacogenetic testing (optional), hematocrit, pregnancy test

Data Collection: Collection of retrospective data

Study summary

This is an observational study of the occurrence of cardiac toxicity in patients with breast cancer,lymphoma or leukemia receiving chemotherapy including an anthracycline. Patients will be identified at the oncology clinic and will be included in the study if all eligible criteria are met. The study will involve retrospective and prospective evaluations.

Safety will be assessed through reporting of serious adverse events (SAEs) related to study procedures.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age 18 years or older at time of CT initiation * Signed informed consent * Patients with diagnosis of breast cancer,lymphoma or leukemia (including autografted subjects) * Planned, ongoing or completed (within last 5 years) chemotherapy with anthracycline * Left ventricular ejection fraction (LVEF) ≥50% pre-chemotherapy * The participant is willing to undergo CMR scans and all other required study procedures Exclusion Criteria: * Known cardiomyopathy and/or LVEF \<50% * Known heart failure * History of myocardial infarction (MI) * Clinically significant cardiac valvular disease * Clinically significant pericardial effusion * Allografted subjects * Contraindications to CMR testing (Cohort A \& prospective evaluation for Cohort B): * Pacemakers, other metallic implants or severe claustrophobia * Weight \> 135 kg * Patients with a history of previous allergic reaction to gadolinium * Patients with history of seizure * Renal insufficiency (eGFR of \< 45ml/min/1.73m2 using the MDRD equation) * Pregnant or breastfeeding women

Primary outcome measure(s)

  • Myocardial extracellular volume (ECV) — Change from baseline to 3, 6, 12,and 24 months
    Cohort A
  • Myocardial extracellular volume (ECV) — Change from baseline to prior study entry, 12 and 24 months post study entry.
    Cohort B

Trial sites (6)

FacilityCityRegionStatus
Centre Hospitalier de l'université de Montréal (CHUM) Montreal Quebec
CIUSSS Ouest de l'ile de Montreal - St-Mary's Hospital Montreal Quebec
CIUSSS de l'Est-de-l'Île-de-Montréal - Hôpital Maisonneuve-Rosemont Montreal Quebec
CIUSSS du Centre-Ouest de l'Île de Montréal - Jewish General Hospital Montreal Quebec
Montreal Heart Institute Montreal Quebec
CISSSS de Lanaudière_Hôpital Pierre LeGardeur (referring site) Terrebonne Quebec (QC)

More Montreal Heart Institute trials in Canada

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Patient SELF-management With HemodynamIc Monitoring: Virtual Heart Failure Clinic and Outcomes Recruiting
Aspirin in Subclinical Coronary Artery Disease: A Pilot Randomised Controlled Trial Recruiting
Home-based Heat Therapy for Type 2 Diabetes Recruiting
Aspirin-free Strategy With Ticagrelor in Patients With a Myocardial Infarction Treated Medically Alone Recruiting

Other trials for the same condition

Improving Quality of Life for Patients With Breast Cancer Invading the Chest Wall: A Prospective Registry For Patients Undergoing Full Thickness Chest Wall Resection Recruiting
Remote Monitoring of Patient Reported Outcomes to Improve the Efficacy of the Acute Phase Radiotherapy Review Process Recruiting
Predicting Breast Cancer With the BRAVE System Recruiting
A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer Recruiting
EXCEL: Exercise for Cancer to Enhance Living Well Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04541212 on ClinicalTrials.gov ↗ ← All trials in Canada