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Biomarkers in Dermal Interstitial Fluid for Early Diagnosis and Follow-up of Cardiovascular Diseases (BIO-ISF-CVD)

A

Ascilion AB

Status

Active, not recruiting

Conditions

Cardiovascular Diseases

Study type

Observational

Funder types

Industry

Identifiers

NCT06632353
CIV-23-08-043912

Details and patient eligibility

About

Sampling of dISF and blood plasma for qualitative measurements.

Full description

Sampling of dISF will be performed to investigate biomarkers in dISF for early diagnosis and follow-up of cardiovascular diseases.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Group 1: Chronic heart failure with stable therapy. NYHA classification II, III and IV. Age > 60 years. Group 2: Age 18-40 years.

Exclusion criteria

  • Participating in another clinical investigation which may affect the study outcome according to clinical judgement.
  • Previous use of sampling system used.
  • Pregnancy or lactating.
  • Any disease or condition that may be affected.
  • Individuals who lack the ability to fully consent to participate in the study.
  • Severe skin injury.
  • Tattoo or piercing close to sampling area.
  • Group 1: All forms of emergency care.
  • Group 1: Non-stable therapy.
  • Group 1: Sepsis.
  • Group 1: BMI > 30kg/m2.
  • Group 1: Age > 84 years.
  • Group 2: Known heart or vascular disease.
  • Group 2: Diabetes.
  • Group 2: Kidney disease.

Trial design

30 participants in 2 patient groups

Group 1
Description:
Cardiovascular diseases
Group 2
Description:
Reference

Trial contacts and locations

1

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Central trial contact

Mikael Hillmering, PhD

Data sourced from clinicaltrials.gov

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