Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
The aim of this study is to identify and evaluate cardiotoxicity in patients with diagnosis of breast cancer, lymphoma or leukemia scheduled to receive anthracycline-based chemotherapy (Cohort A: prospective evaluation); and patients undergoing or having received within the last 5 years anthracycline-based chemotherapy (Cohort B: retrospective and prospective evaluations). Part A and B will be conducted in parallel. This study also has the objectif of identifying biomarkers of cardiotoxicity including inflammatory response proteins and clonal hematopoiesis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Prospective |
| |
| Cohort B | Retrospective/Prospective |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Imaging | Diagnostic Test | Cardiac Imaging: echography, ECG, MRI Blood tests: Lipid profile, hs-CRP, metabolic markers, HDL functionality, pharmacogenetic testing (optional), hematocrit, pregnancy test |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial extracellular volume (ECV) | Cohort A | Change from baseline to 3, 6, 12,and 24 months |
| Myocardial extracellular volume (ECV) | Cohort B | Change from baseline to prior study entry, 12 and 24 months post study entry. |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular (LV) systolic function (global and regional) | Cohort A | Change from baseline to 3, 6, 12,and 24 months. |
| Biomarker of myocardial injury (high-sensitivity troponin (hs-cTn)) | Cohort A |
Not provided
Inclusion Criteria:
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):
Not provided
Not provided
Not provided
Not provided
225 patients enrolled from oncology clinics. Patients will be screened and identified at the oncology clinics. The prospective cardiac evaluations including New York Heart Association (NYHA) functional classification, transthoracic echocardiography, CMR, standard 12-lead electrocardiogram (ECG), cardiac biomarkers, lipid profile & HDL functionality tests will be performed at the Montreal Heart Institute (MHI).
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jean-Claude Tardif, MD | Montreal Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de l'université de Montréal (CHUM) | Montreal | Quebec | H2X0C1 | Canada | ||
| CIUSSS Ouest de l'ile de Montreal - St-Mary's Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Data Collection | Other | Collection of retrospective data |
|
| Change from baseline to 3, 6, 12,and 24 months. |
| Biomarker of elevated LV fitting pressure (N-Terminal-pro-hormone B-type Natriuretic Peptide (NT-proBNP)) | Cohort A | Change from baseline to 3, 6, 12,and 24 months. |
| Biomarker of inflammation (high-sensitivity C-reactive protein (hs-CRP)) | Cohort A | Change from baseline to 3, 6, 12,and 24 months. |
| Clonal hematopoiesis associated gene mutations. | Cohort A | Change from baseline to 24 months.. |
| Telomere length measurement | Cohort A | Change from baseline to 24 months.. |
| Left ventricular (LV) systolic function (global and regional) | Cohort B | Change from study entry to 12 and 24 months. |
| Biomarker of myocardial injury (high-sensitivity troponin (hs-cTn)) | Cohort B | Change from study entry to 12 and 24 months. |
| Biomarker of elevated LV fitting pressure (N-Terminal-pro-hormone B-type Natriuretic Peptide (NT-proBNP)) | Cohort B | Change from study entry to 12 and 24 months. |
| Biomarker of inflammation (high-sensitivity C-reactive protein (hs-CRP)) | Cohort B | Change from study entry to 12 and 24 months. |
| Clonal hematopoiesis associated gene mutations. | Cohort B | Change from baseline to 24 months.. |
| Telomere length measurement | Cohort B | Change from baseline to 24 months.. |
| Montreal |
| Quebec |
| H3T 1M5 |
| Canada |
| CIUSSS de l'Est-de-l'Île-de-Montréal - Hôpital Maisonneuve-Rosemont | Montreal | Quebec | Canada |
| CIUSSS du Centre-Ouest de l'Île de Montréal - Jewish General Hospital | Montreal | Quebec | Canada |
| Montreal Heart Institute | Montreal | Quebec | Canada |
| CISSSS de Lanaudière_Hôpital Pierre LeGardeur (referring site) | Terrebonne | Quebec (QC) | J6V 2H2 | Canada |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D008223 | Lymphoma |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006402 | Hematologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
Not provided
Not provided