Cardiovascular DiseasesBIO-ISF-CVDNCT06632353
Biomarkers in Dermal Interstitial Fluid for Early Diagnosis and Follow-up of Cardiovascular Diseases
An observational study of Cardiovascular Diseases, run by Ascilion AB at 1 site in Sweden.
Trial summary
Sampling of dISF and blood plasma for qualitative measurements. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 8 Oct 2024to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Healthy volunteers and subjects recruited at hospital
Who may be able to join
- Group 1: Chronic heart failure with stable therapy. NYHA classification II, III and IV. Age > 60 years. Group 2: Age 18-40 years.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Sampling of dISF and blood plasma for qualitative measurements.
Read the detailed description
Sampling of dISF will be performed to investigate biomarkers in dISF for early diagnosis and follow-up of cardiovascular diseases.
- Conditions
- Cardiovascular Diseases
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Cardiovascular diseases | |
| Group 2 | Reference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of dISF biomarker
Presence or not
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start8 Oct 2024
- Primary completion5 Nov 2025
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ascilion AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632353
- Sponsor's protocol ID
- CIV-23-08-043912
- Acronym
- BIO-ISF-CVD
- Status last verified
- Jan 2026
- First submitted
- 7 Oct 2024
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will probably be published
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Dermal Interstitial Fluid for Early Diagnosis and Follow-up of Cardiovascular Diseases
- ClinicalTrials.gov ID
- NCT06632353
- Acronym / sponsor ID
- BIO-ISF-CVD / CIV-23-08-043912
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ascilion ABIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 5 Nov 2025 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Cardiovascular diseases |
| Group 2 | – | –Reference |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers and subjects recruited at hospital
Key inclusion criteria (1 listed)
- Group 1: Chronic heart failure with stable therapy. NYHA classification II, III and IV. Age > 60 years. Group 2: Age 18-40 years.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of dISF biomarker
Time frame: Day 1
Presence or not
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: Undecided. Will probably be published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Ascilion AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of dISF biomarker (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.