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ACTIVE NOT RECRUITING NA

CardioSeq: Impact of WGS in Individuals With CVD

NCT05656183 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • DIAGNOSTIC_TEST TruGenome Cardiovascular Disease test

Study Locations (1)

Michigan

  • Henry Ford Health System — Detroit

Trial Details

FieldValue
Enrollment Target 1,500 participants
Start Date 2023-01-06
Est. Completion 2025-06
Phase NA

Sponsor

Illumina

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05656183

The ClinicalTrials.gov registry entry for NCT05656183 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Illumina, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Cardiovascular Diseases appearing as the primary indexed condition, and to 1 intervention — of which TruGenome Cardiovascular Disease test is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05656183 reports 1 study location spanning 1 distinct geographic area — top geographies include Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05656183 about?

NCT05656183 is a clinical study titled "CardioSeq: Impact of WGS in Individuals With CVD". 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 with...

What is the current status of trial NCT05656183?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 1,500 participants. The study started on 2023-01-06. Estimated completion is 2025-06.

What conditions does trial NCT05656183 study?

This clinical trial studies the following conditions: Cardiovascular Diseases. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05656183?

The interventions under investigation include: TruGenome Cardiovascular Disease test (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05656183?

This trial is sponsored by Illumina, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05656183 being conducted?

This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial