Myocardial Perfusion and Fibrosis in Cancer Survivors
Status: | Suspended |
---|---|
Conditions: | Cardiology, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 21 - 85 |
Updated: | 3/9/2019 |
Start Date: | November 13, 2017 |
End Date: | December 2019 |
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).
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.
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.
Inclusion Criteria :
1. Cancer patients must have Stage I-III breast cancer or lymphoma and have received an
anthracycline agent during treatment at least 2 years prior to enrollment in this
study.
2. Age-matched to cancer survivor with no history of cancer or anthracycline treatment.
3. Age 21-85 years of age at the time of enrollment.
4. ECOG or Karnofsky performance status of 0-1.
5. Life expectancy of greater than 3 months.
6. Enrolled control participants must have normal creatinine clearance of >60 mL/min/1.73
m2 for patients with creatinine levels above institutional normal.
7. Ability to understand and the willingness to sign an IRB-approved informed consent
document (either directly or via a legally authorized representative).
Exclusion Criteria :
1. History of allergic reactions attributed to compounds of similar chemical or biologic
composition to gadolinium contrast agents or adenosine or history of kidney disease.
2. Those with contraindications for MRI such as ferromagnetic cerebral aneurysm clips or
other intracranial metal, pacemakers, defibrillators, functioning neurostimulator
devices or other implanted electronic devices.
3. Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.
4. Pregnant women are excluded from this study because the use of gadolinium in cardiac
MRI imaging may not be safe in pregnant women. Because some methods of birth control
are not 100% reliable, a pregnancy test is required if the participant is a) a
sexually active woman of childbearing potential or b) a sexually active peri or
post-menopausal women whose last normal menstrual period was less than 12 months ago.
5. Coronary revascularization in the past 6 months or known severe multi-vessel CAD
previously determined to be not amendable to mechanical intervention.
6. Ongoing, unrelieved symptoms thought to represent cardiac ischemia and requiring
immediate cardiac catheterization
7. History of COPD or asthma
We found this trial at
2
sites
1 Medical Center Boulevard
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
Principal Investigator: Jennifer Jordan, PhD
Phone: 336-713-7085
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