An observational study in Myocardial Fibrosis, Myocardial Injury and Chemotherapeutic Toxicity, sponsored by Virginia Commonwealth University. Completed at 2 sites in United States. Open to participants aged 21 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-30.
Sponsored by Virginia Commonwealth University · Observational
This is a cross-sectional pilot study. The investigators seek to obtain early information pertaining to the relationship between measurements of myocardial perfusion reserve and myocardial fibrosis after receipt of Anthracycline-based chemotherapy (≥2 years prior).
The primary objective of this cross-sectional pilot study is to determine the myocardial perfusion reserve index (MPRI) in cancer survivors treated with anthracycline chemotherapy relative to similarly aged healthy comparators without a history of cancer treatment. Hypothesis: Cancer survivors treated with anthracycline chemotherapy will have a lower MPRI than similarly aged healthy comparators without a history of cancer treatment.The secondary objective of this cross-sectional pilot study is to determine if MPRI is associated with myocardial fibrosis measured non-invasively with cardiovascular magnetic resonance imaging. Hypothesis: MPRI will be inversely associated with fibrosis burden
Study participants will be consented with pre-study data collection recorded. No randomization will occur as this is a cross-sectional study. Participants in both the cancer survivor and control groups will complete one study visit. No follow-up will be completed.
3,255 studies on the registry are indexed under Fibrosis; 465 are open to participants now.
This study's enrollment of 7 is below the median of 110 across 973 observational studies indexed under Fibrosis.
Browse Fibrosis studies →Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.
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The investigators will enroll 10 eligible and consenting men and women aged 21-85 years who either currently have or have had cancer who began their cancer treatment at least 2 years prior to this study and have received anthracycline based chemotherapy. The investigators will enroll an additional group of 6 men and women without cancer or a prior history of a cardiovascular event, matched to 5-year age range with our post-cancer treatment participants
Exclusion Criteria :
Cancer patients with Stage I-III breast cancer or lymphoma that have received an anthracycline agent during treatment at least 2 years prior to enrollment in this study. Adenosine stress test MRI will be performed.
Diagnostic Test: Adenosine stress test MRI
Age-matched Healthy Control to cancer survivor with no history of cancer or anthracycline treatment. Adenosine stress test MRI will be performed.
Diagnostic Test: Adenosine stress test MRI
Participants will receive a contrasted adenosine stress CMR examination on a 1.5T Siemens Avanto scanner (Siemens Medical Solutions, Malvern, PA) dedicated to cardiovascular imaging. Adenosine stress was selected due to attenuated endothelium dependent and -independent vasodilation after doxorubicin receipt in humans to allow the investigators to understand the potential effect of perivascular fibrosis on perfusion reserve. Standardized CMR protocols will be performed to measure LV volumes (to assess wall motion abnormalities and identify any potential myocardial dysfunction), Native T1, ECV, and myocardial perfusion reserve in the short-axis plane
Also known as: MRI, Stress Test
Myocardial perfusion reserve index (MPRI)
The myocardial perfusion reserve index (MPRI) will be measured noninvasively with adenosine stress CMR imaging after dual-bolus first-pass perfusion with gadolinium contrast. The slope of the myocardial signal intensity curve is computed and normalized by the slope of the blood pool signal intensity curve for both rest and stress. MPRI is calculated as the ratio of the stress slope divided by the rest slope.
Time frame: During Adenosine Stress Test
Myocardial fibrosis quantification using Myocardial T1
Measured noninvasively with CMR imaging. For myocardial fibrosis quantification with T1 endocardial and epicardial contours are drawn to delineate the myocardium; mean T1 (pre- and post-contrast) is calculated from the pixels within the myocardium. Expected range of T1 is 900-1250ms with higher T1 values considered a worsened outcome.
Time frame: During Adenosine Stress Test
Myocardial fibrosis quantification using extracellular volume (ECV)
Measured noninvasively with CMR imaging. The ECV is calculated from the mean myocardial T1 and LV blood T1 pre- and post-contrast. Expected range of ECV is 20-40% with higher ECV values representing a worse outcome.
Time frame: During Adenosine Stress Test
Plan to share: No
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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Virginia Commonwealth University