Cardiac Fibrosis and Risk Prediction in Cancer Treatment-Related Cardiotoxicity
Sponsor
University of Minnesota (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02798679
Collaborator
(none)
40
1
73
0.5
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether pre-existing cardiac fibrosis is a predictor of cancer treatment-related cardiotoxicity.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Cardiac Fibrosis and Risk Prediction in Cancer Treatment-Related Cardiotoxicity
Study Start Date
:
Aug 1, 2016
Anticipated Primary Completion Date
:
Sep 1, 2022
Anticipated Study Completion Date
:
Sep 1, 2022
Outcome Measures
Primary Outcome Measures
- Cardiotoxicity assessed clinically or by cardiac MRI [24 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
45 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Stage I-III breast cancer or lymphoma with a >2 year life expectancy
-
A treatment plan that includes anthracyclines and/or trastuzumab
-
Age >45 years
-
Able to hold breath for 10 seconds
-
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion Criteria:
-
Refusal or inability to provide informed consent
-
Known heart failure or LVEF <50%
-
Heart rate over 100 bpm
-
Renal dysfunction with GFR <30 mL/min/1.73m2
-
Participants with pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices
-
Symptomatic claustrophobia
-
Plans to move within 24 months of enrollment
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
Sponsors and Collaborators
- University of Minnesota
Investigators
- Principal Investigator: Chetan Shenoy, MBBS, University of Minnesota
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University of Minnesota
ClinicalTrials.gov Identifier:
NCT02798679
Other Study ID Numbers:
- CV-2016-24434
First Posted:
Jun 14, 2016
Last Update Posted:
May 2, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms: