Biomarkers in Dermal Interstitial Fluid for Early Diagnosis and Follow-up of Cardiovascular Diseases

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06632353

Acronym

BIO-ISF-CVD

Enrollment

Registered

2024-10-09

Start date

2024-10-08

Completion date

2026-06-30

Last updated

2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Brief summary

Sampling of dISF and blood plasma for qualitative measurements.

Detailed description

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Presence of dISF biomarker	Day 1	Presence or not

Countries

Sweden

Outcome results