Clinical trial NCT03191461: Myocardial Perfusion and Fibrosis in Cancer Survivors
Official title: Myocardial Perfusion and Fibrosis in Cancer Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Fibrosis
Myocardial Injury
Chemotherapeutic Toxicity
Keywords: Anthracycline-based chemotherapy
Anth-bC
Chemotherapy
Myocardial Perfusion
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Wake Forest University
First posted: 2017-06-19
Enrollment: 7
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Myocardial perfusion reserve index (MPRI)
timeFrame: During Adenosine Stress Test
Secondary outcomes:
measure: Myocardial fibrosis quantification using Myocardial T1
timeFrame: During Adenosine Stress Test
measure: Myocardial fibrosis quantification using extracellular volume (ECV)
timeFrame: During Adenosine Stress Test
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Heath
state: North Carolina
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Jennifer H Jordan, PhD
role: PRINCIPAL_INVESTIGATOR
References: