Myocardial Perfusion and Fibrosis in Cancer Survivors

Completed

• Conditions: Myocardial Injury; Myocardial Fibrosis; Chemotherapeutic Toxicity
• Interventions: Diagnostic Test: Adenosine stress test MRI

• Registration Number: NCT03191461
• Lead Sponsor: Virginia Commonwealth University

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-05-25
• Study First Submitted QC: 2017-06-16
• Study First Posted: 2017-06-19
• Study Start: 2017-11-13
• Primary Completion: 2024-04-11
• Study Completion: 2024-04-11
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Controls	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.
Cancer Patients	Adenosine stress test MRI	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.

Primary Outcome Measures

Name	Time	Method
Myocardial perfusion reserve index (MPRI)	During Adenosine Stress Test	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.

Secondary Outcome Measures

Name	Time	Method
Myocardial fibrosis quantification using Myocardial T1	During Adenosine Stress Test	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.
Myocardial fibrosis quantification using extracellular volume (ECV)	During Adenosine Stress Test	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.

Trial Locations

Locations (2)

Wake Forest Baptist Heath; 🇺🇸 Winston-Salem, North Carolina, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States