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NCT05656183
CardioSeq: Impact of WGS in Individuals With CVD
Conditions: Cardiovascular Diseases
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 1500
Sponsor: Illumina, Inc.
Location: United States
Summary
This is a prospective, single-center, open-label study to investigate the diagnostic efficacy of the TruGenome CVD test and its impact on clinical management compared to usual care in individuals with cardiovascular disease.
Diagnostic yield and changes of management (CoM) will be assessed both within the WGS group and compared to a contemporaneous, matched (2:1) usual care (UC) group sourced from EHR records.
Eligibility Criteria
Inclusion Criteria:Individuals ≥18 years of ageStable ambulatory patients with a cardiology visit within the past year or scheduled within the next 90 days.At least one of the following clinical diagnoses:A. Any aortopathy, B. Dyslipidemia, C. Coronary or peripheral arterial disease, D. Heart Failure or cardiomyopathy, E. Any arrythmiaMust be able to read, understand, and sign an informed consentExclusion Criteria:Individuals with a previously confirmed molecular diagnosis of a known genetic disease with an associated cardiovascular phenotype inclusive of monogenic cardiovascular diseases, chromosomal aneuploidies, and microdeletion disorders.Bone marrow transplant recipientsIndividuals with severe cognitive dysfunction or diminished capacity who are unable to provide informed consentPatients undergoing active chemotherapy treatment for cancerPatients with end-stage renal diseasePatients with poor medical prognosis with a life expectancy <1 yearPrincipal Investigator decides for any reason the study is not in the best interest of the patient
Source: ClinicalTrials.gov (NCT05656183). StuddyBuddy aggregates publicly available trial information.