NCT03191461

Myocardial Perfusion and Fibrosis in Cancer Survivors

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 7 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Myocardial Fibrosis
• Myocardial Injury
• Chemotherapeutic Toxicity

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-11-13
• Primary completion: 2024-04-11
• Completion: 2024-04-11
• First posted: 2017-06-19
• Last updated: 2024-10-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study