Mutational Analysis as a Prognostic and Predictive Marker of Cardiovascular (CVD) Disease in Patients With Myelodysplasia
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|ClinicalTrials.gov Identifier: NCT04110925|
Recruitment Status : Not yet recruiting
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|MDS Cardiovascular Diseases Inflammation||Genetic: Genetic Mutations Other: Inflammatory and lipid markers Other: Computed Tomography (CT) of the heart||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mutational Analysis as a Prognostic and Predictive Marker of Cardiovascular Disease in Patients With Myelodysplasia|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2021|
All Canadian MDS patients on the MDS-database to be included.
Genetic: Genetic Mutations
DNA sequencing for mutations to be obtained by bloodwork within 6 months of diagnosis, or by accessing diagnostic bone marrow aspirate slides.
Other: Inflammatory and lipid markers
Bloodwork to be done for lipid profile, c-reactive protein (CRP), and multiplex chemokine/cytokine analysis.
Other: Computed Tomography (CT) of the heart
Sunnybrook Patients with no history of cardiovascular disease [ex: past/present coronary artery disease (CAD), peripheral vascular disease (PVD), angina, myocardial infarction (MI), stroke, transient ischemic attack (TIA), or stents], not pregnant, and able to undergo CT will receive a CT of the heart to look for and quantify any occult coronary artery disease.
- Measure the allelic frequency and type of myeloid cancer-associated mutations in MDS patients diagnostic bone marrow aspirates or slides [ Time Frame: 2 years ]Screen for Presence of myeloid-cancer associated mutations and their variant allele frequencies (VAF) at diagnosis of MDS as measured through next generation sequencing of 40 myeloid genes.
- Screen for occult and potentially clinically significant CAD in MDS patients by means of coronary CT [ Time Frame: 2 years ]
Patients at Sunnybrook hospital with no pre-existing history of CAD who receive CT of the heart and found to harbour occult CAD by means of coronary calcium scoring:
- zero calcium (No CAD)
- 1-400: mild-moderate calcification
- >400: severe calcification
- Identify any correlation between selected myeloid mutations and/or their VAF with the presence of pre-existing incident or occult CAD [ Time Frame: 2 years ]Comparing the presence of myeloid-cancer associated mutations and their variant allele frequencies (VAF) at diagnosis of MDS as measured through next generation sequencing of 40 myeloid genes between patients with pre-existing/occult CAD and those without.
- Track how often newly discovered CAD from coronary CT leads to further intervention or changes in monitoring [ Time Frame: 2 years ]
The investigators will track any interventions in patients without a prior history of CAD who who are discovered to have occult CAD by coronary CT. This includes number of patients who were recommended:
- medical management of CAD
- Referral to clinical cardiologist
- Invasive angiography
- Screen for serum inflammatory cytokines in the blood of patients with incident or occult CAD [ Time Frame: 2 years ]Measure TNFa, IL-1beta, IL-6 and an array of other inflammatory cytokines (to be determined) in the peripheral blood upon enrollment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110925
|Contact: Rena Buckstein, MDfirstname.lastname@example.org|
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Principal Investigator:||Rashmi S Goswani, MD||Sunnybrook Health Sciences Centre|