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Recruiting NCT07001007

NCT07001007 SCAPIS 2 Cardio - Vibrometer Based Pulse Wave Analysis and CVD Risk Assessment

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Clinical Trial Summary
NCT ID NCT07001007
Status Recruiting
Phase
Sponsor HJN Sverige AB/Neko Health
Condition Coronary Arterial Disease (CAD)
Study Type OBSERVATIONAL
Enrollment 1,600 participants
Start Date 2024-07-01
Primary Completion 2026-06

Eligibility & Interventions

Sex All sexes
Min Age 58 Years
Max Age 72 Years
Study Type OBSERVATIONAL
Interventions
Coronary Computer Tomography (CCTA)Laser Doppler Vibrometry and single-lead ECGEchocardiography

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 1,600 participants in total. It began in 2024-07-01 with a primary completion date of 2026-06.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

This clinical investigation will evaluate a novel contactless technology for assessing arterial stiffness and pulse wave characteristics and explore its potential in assessment of coronary artery disease, aortic stenosis and heart failure, in a population-based sample aged 58-72 years. It will be the first in clinical setting, pilot stage, observational investigation to evaluate the clinical safety, performance and diagnostic accuracy of Cardio P4, a laser-doppler vibrometry (LDV) and microwave radar-based device.

Eligibility Criteria

Inclusion Criteria: * Subjects already included in the main / general SCAPIS 2 study at Danderyd Hospital in Stockholm, and of which has also participated in the echocardiography examination Exclusion Criteria: * Patients unable to provide an informed consent

Contact & Investigator

Central Contact

Mattias Windå

✉ mattias@nekohealth.com

📞 +46703169040

Principal Investigator

Professor Jonas Spaak, MD, PhD

PRINCIPAL INVESTIGATOR

Karolinska Institute, Department of Clinical Sciences, Danderyd Hospital, Division of Cardiovascular Medicine, Stockholm, Sweden

Frequently Asked Questions

Who can join the NCT07001007 clinical trial?

This trial is open to participants of all sexes, aged 58 Years or older, up to 72 Years, studying Coronary Arterial Disease (CAD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07001007 currently recruiting?

Yes, NCT07001007 is actively recruiting participants. Contact the research team at mattias@nekohealth.com for enrollment information.

Where is the NCT07001007 trial being conducted?

This trial is being conducted at Stockholm, Sweden.

Who is sponsoring the NCT07001007 clinical trial?

NCT07001007 is sponsored by HJN Sverige AB/Neko Health. The principal investigator is Professor Jonas Spaak, MD, PhD at Karolinska Institute, Department of Clinical Sciences, Danderyd Hospital, Division of Cardiovascular Medicine, Stockholm, Sweden. The trial plans to enroll 1,600 participants.

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