Clinical trial NCT05201014: Cancer Survivor Cardiomyopathy Detection
Official title: CAncer Survivor CArdiomyopathy DEtection Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Miami Heart Research Institute
First posted: 2022-01-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 cancer survivors who are 1 year out from anthracycline-based therapy.

Brief summary: The purpose of this study is to improve the cardiovascular care of adult cancer survivors. The goal is to obtain the data necessary to plan and develop a nation-wide network of a screening program that can help provide cost-effective and long-term monitoring.

Detailed description: The primary objective of this study is to define the diagnostic performance and optimal cutoffs of AI-ECG and NT-pro-BNP for the detection of left ventricular dysfunction \[LVD, defined as a left ventricular ejection fraction (LVEF) \<50%\] in cancer patients at 1 year after completion of anthracycline-based chemotherapy.

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age prior to enrollment and anthracycline start date
* Diagnosis of breast cancer, lymphoma, or sarcoma with either planned or at 1 year after completion of anthracycline therapy, including patients from 6-12 months and greater than 1 year post-anthracycline exposure.
* Patients with a history of persistent atrial fibrillation (afib) that are not in afib remission. Include if the most recent ECG does not show afib. Atrial flutter treated the same

Exclusion Criteria:

* LVEF \<50% or prior confirmed history of cardiomyopathy, heart failure, left bundle branch block, or paced rhythm
* Patients with a history of persistent atrial fibrillation (afib) that are not in afib remission. Include if the most recent ECG does not show afib. Atrial flutter treated the same.
* Individuals with pacemakers, defibrillators, or other implanted electronic devices
* Inability/unwillingness of individual to give written informed consent

Primary outcomes:
measure: Diagnostic performance of AI-ECG for left ventricular ejection fraction (LVEF) < 50%
timeFrame: 1 year post anthracycline therapy
measure: Diagnostic performance of NT-pro-BNP for left ventricular ejection fraction (LVEF) < 50%
timeFrame: 1 year post anthracycline therapy
measure: Diagnostic performance of AI-ECG and NT-pro-BNP for left ventricular ejection fraction (LVEF) < 50%
timeFrame: 1 year post anthracycline therapy
Secondary outcomes:
measure: Absolute change in LVEF from baseline to 1 year from anthracycline-based therapy
timeFrame: 1 year
measure: Absolute change in AI-ECG probability for LVEF <50% from baseline to 1 year from anthracycline-based therapy
timeFrame: 1 year
measure: Correlation of change in LVEF and AI-ECG probability of LVEF <50% from baseline to 1 year from anthracycline-based therapy
timeFrame: 1 year
measure: Absolute change in NT-pro-BNP from baseline to 1 year from anthracycline-based therapy
timeFrame: 1 year
measure: Correlation of change in LVEF and NT-pro-BNP from baseline to 1 year from anthracycline-based therapy
timeFrame: 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Joerg Herrmann, MD
role: PRINCIPAL_INVESTIGATOR
References: