Cardiovascular DiseasesLP-I-CARDIAGNCT05987904
Feasibility Study for Instant Cardiac Diagnostic and Post-operative Risk Assessment with the LynxPatch Device
An observational study of Cardiovascular Diseases and Heart Diseases, run by Lynx Health Science GmbH at 1 site in Germany.
Trial summary
In this clinical study the investigators will evaluate if it is feasible to pre-operatively identify low-risk patients, and to identify patients with cardiac pathologies with the LynxPatch. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases
- What is being tested?
- LynxPatch
- Type of treatment
- Medical device
- How many people
- 1,097 participants
- Where
- 1 siteGermany
- Study dates
- 2 Oct 2023to 20 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: In this study, all patients will be consecutively recruited that are either scheduled for an echocardiographic examination or that will be subjected to a non-cardiac surgical procedure according to their respective standard procedure.
Who may be able to join
- Provision of informed consent, i.e., the subject must be able to understand and sign the Patient Information and Consent Form.
- Group 1: Patients that have an indication for an echocardiographic assessment.
- Group 2: Patients that are scheduled for a non-cardiac surgery
Who cannot join
- Subjects has implanted cardioverter defibrillator
- Subject is pregnant
- Subject is breastfeeding
- Subject has compromised skin in the location where the LynxPatch is intended to be positioned
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MDR - Feasibility Study for Instant Cardiac Diagnostic and Post-operative Risk
In this clinical study the investigators will evaluate if it is feasible to pre-operatively identify low-risk patients, and to identify patients with cardiac pathologies with the LynxPatch.
Read the detailed description
The LynxPatch is a non-invasive, wireless device for cardiac diagnosis. The aim of this study is to compare the LynxPatch predictions with the echocardiographic diagnoses of cardiac pathologies and to evaluate its perioperative risk predictions in non-cardiac surgeries. The study population includes 1100 patients that scheduled for an echocardiographic assessment or for a non-cardiac surgery. The LynxPatch measurement procedure has a duration of about 30 minutes.
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Being tested
- LynxPatch
- Keywords
- Cardiac Diagnosis
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LynxPatchDevice
Measurements with the LynxPatch device are conducted.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Cardiologic Group | This group includes patients who are scheduled for echocardiography. Receives: Device: LynxPatch | |
| Group 2: Surgery Group | This group includes patients that are scheduled for non-cardiac surgery. Receives: Device: LynxPatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of agreement between the LynxPatch device and echocardiography in detecting a cardiac pathology.
Comparison of the detection of the presence of a cardiac pathology by the LynxPatch device and by echocardiography-based expert diagnosis.
Measured: 30 minutes per individual
Secondary outcomes (3)
Accuracy of the LynxPatch device predictions of an adverse perioperative outcome
Comparison of the LynxPatch device predictions of an adverse perioperative outcome with actually occuring adverse perioperative outcome.
Measured: 30 days per individual
Usability of the LynxPatch device
Evaluation of aspects of the LynxPatch device's usability by interviewing study participants using a questionnaire.
Measured: 30 minutes per individual
Rate of LynxPatch-related safety incidents
Assessment of safety-related aspects with the LynxPatch device. Relevant incidents include Adverse Device Effects, Serious Adverse Device Effects and Device Defficiencies.
Measured: 30 minutes per individual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start2 Oct 2023
- Primary completion20 Jun 2024
- Study completion20 Jun 2024
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 only
- Time perspective
- Prospective
- Enrolment
- 1,097 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lynx Health Science GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Meditrial Europe Ltd.
- Responsible party
- Sponsor
- Investigators
- Aydan Ewers, Dr. med., Principal investigator, BG Universitätsklinikum Bergmannsheil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987904
- Sponsor's protocol ID
- MDR LP-I-CARDIAG
- Acronym
- LP-I-CARDIAG
- Status last verified
- Oct 2024
- First submitted
- 28 Jul 2023
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MDR - Feasibility Study for Instant Cardiac Diagnostic and Post-operative Risk
- ClinicalTrials.gov ID
- NCT05987904
- Acronym / sponsor ID
- LP-I-CARDIAG / MDR LP-I-CARDIAG
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Keywords
- Cardiac Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,097 participants (actual)
- Lead sponsor
- Lynx Health Science GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Meditrial Europe Ltd.
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 14 Aug 2023 (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.
In this clinical study the investigators will evaluate if it is feasible to pre-operatively identify low-risk patients, and to identify patients with cardiac pathologies with the LynxPatch.
Detailed description
The LynxPatch is a non-invasive, wireless device for cardiac diagnosis. The aim of this study is to compare the LynxPatch predictions with the echocardiographic diagnoses of cardiac pathologies and to evaluate its perioperative risk predictions in non-cardiac surgeries. The study population includes 1100 patients that scheduled for an echocardiographic assessment or for a non-cardiac surgery. The LynxPatch measurement procedure has a duration of about 30 minutes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Cardiologic Group | – | Device: LynxPatchThis group includes patients who are scheduled for echocardiography. |
| Group 2: Surgery Group | – | Device: LynxPatchThis group includes patients that are scheduled for non-cardiac surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this study, all patients will be consecutively recruited that are either scheduled for an echocardiographic examination or that will be subjected to a non-cardiac surgical procedure according to their respective standard procedure.
Key inclusion criteria (3 listed)
- Provision of informed consent, i.e., the subject must be able to understand and sign the Patient Information and Consent Form.
- Group 1: Patients that have an indication for an echocardiographic assessment.
- Group 2: Patients that are scheduled for a non-cardiac surgery
Key exclusion criteria (4 listed)
- Subjects has implanted cardioverter defibrillator
- Subject is pregnant
- Subject is breastfeeding
- Subject has compromised skin in the location where the LynxPatch is intended to be positioned
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LynxPatchMeasurements with the LynxPatch device are conducted. | Device | Group 1: Cardiologic Group, Group 2: Surgery Group |
Primary outcome
Level of agreement between the LynxPatch device and echocardiography in detecting a cardiac pathology.
Time frame: 30 minutes per individual
Comparison of the detection of the presence of a cardiac pathology by the LynxPatch device and by echocardiography-based expert diagnosis.
3 secondary outcomes
Accuracy of the LynxPatch device predictions of an adverse perioperative outcome
Time frame: 30 days per individual
Usability of the LynxPatch device
Time frame: 30 minutes per individual
Rate of LynxPatch-related safety incidents
Time frame: 30 minutes per individual
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Aydan Ewers, Dr. med. principal investigator
BG Universitätsklinikum Bergmannsheil
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 and Heart Diseases, run by Lynx Health Science GmbH at 1 site in Germany.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 30 Oct 2024. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Level of agreement between the LynxPatch device and echocardiography in detecting a cardiac pathology. (time frame: 30 minutes per individual). 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 30 Oct 2024.