Atherosclerotic PlaqueNCT05096637
Digital Secondary Prevention in Cardiovascular Disease
A study testing PreventiPlaque App in people with Atherosclerotic Plaque, run by University Hospital, Essen.
Trial summary
Although advances in knowledge of the prevention, diagnosis and treatment of atherothrombosis are encouraging, cardiovascular diseases (CVD), with acute and chronic ischemic heart disease in particular, remain a major cause of disability and premature death throughout the world. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Atherosclerotic Plaque
- What is being tested?
- PreventiPlaque App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to Jul 2023
- Phase
- Interventional
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ultrasound evidence of atherosclerotic plaque in one or both carotid arteries
- Own a smartphone and know how to use apps
- presumed life expectancy of more than one year
- willing to comply with the protocol and provide written informed consent
Who cannot join
- congestive heart failure with NYHA (New York Heart Association classification) III-IV symptoms
- severe valve disease
- no german knowledge
- unwillingness to user the app and/or undergo diagnostic procedures
About this study
Official title: PreventiPlaque - Digital Secondary Prevention in Cardiovascular Disease to Improve Therapy Adherence
Although advances in knowledge of the prevention, diagnosis and treatment of atherothrombosis are encouraging, cardiovascular diseases (CVD), with acute and chronic ischemic heart disease in particular, remain a major cause of disability and premature death throughout the world.
Cardiac rehabilitation (CR) and secondary prevention are coordinated multidimensional evidence-based strategies that aim to assist patients with acute and chronic ischemic heart disease return to an active and satisfying life and to prevent the recurrence of further cardiac events. Since CR is time limited after an acute event, secondary prevention proposes a continuum where care is provided for the rest of a person's life according to the existence of cardiovascular risk factors. Secondary prophylaxis is fundamental for the recovery of the patient, but in most cases, it is only insufficiently implemented.
Read more
To ensure adequate resources for the delivery of health care and to further improve the level of care, care-delivery models need to be changed in a way that patients themselves become more involved in their own care. Mobile health (mHealth) is a rapidly growing health delivery methodology with the potential to impact on health care research, health care delivery and health outcomes.
Therefore, the aim of the study is to determine the impact of plaque visualization using a digital intervention on treatment adherence to improve the cardiovascular risk profile. Participants will be randomized into two groups: intervention group and control group. Participants of the control group receive the best medical care according to current guideline recommendations without access to the app. Participants of the intervention group receive the best medical care according to current guideline recommendations with full access to the Smartphone application at time of study begin until the completion of the follow-up period of 12 months. The access to the app includes access to relevant findings including ultrasound images of the carotid artery, lipid profile, blood pressure values, and weight.
- Conditions
- Atherosclerotic Plaque
- Being tested
- PreventiPlaque App
- Medical subject headings
- Plaque, Atherosclerotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PreventiPlaque AppOther
PreventiPlaque is an app that supports patients with atherosclerotic plaque by strengthening their adherence.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Patients receive the best medical care according to current guideline recommendations without access to the app |
| intervention group | Experimental | Patients receive the best medical care according to current guideline recommendations with full access to the app. This includes access to relevant findings including ultrasound images of the carotid artery, lipid profile, blood pressure values, and weight. Receives: Other: PreventiPlaque App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiovascular risk profile
Measured via SCORE2 (Systematic Coronary Risk Evaluation) risk calculator
Measured: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
Secondary outcomes (8)
Change in LifeSimple7-Score
Measured by Score released by the American Heart Association (AHA)
Measured: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
Change in LDL-cholesterol
measured in mg/dl
Measured: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
Change in body weight
measured in kg
Measured: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
Change in blood pressure
measured in mmHg
Measured: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
Reported physical activity
measured via self-report question
Measured: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
Change in cigarette dependency
asses via Fagerstrom Test for Cigarette Dependence
Measured: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
Change in reported medication adherence
assessed via self-report question
Measured: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
Satisfaction with outpatient care
assessed via questionnaire "Satisfaction in outpatient care)
Measured: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study startNov 2021 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atherosclerotic PlaqueStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Lortz, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096637
- Sponsor's protocol ID
- 20-9157-BO
- Status last verified
- Oct 2021
- First submitted
- 15 Oct 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ullrich G, Bauerle A, Jahre LM, Paldan K, Rosemeyer J, Kalaitzidis C, Rammos C, Teufel M, Rassaf T, Lortz J. Impact of visual presentation of atherosclerotic carotid plaque on cardiovascular risk profile using mHealth technologies. NPJ Digit Med. 2025 Jan 22;8(1):47. doi: 10.1038/s41746-024-01423-y.
PubMed 39843925
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PreventiPlaque - Digital Secondary Prevention in Cardiovascular Disease to Improve Therapy Adherence
- ClinicalTrials.gov ID
- NCT05096637
- Acronym / sponsor ID
- 20-9157-BO
- Conditions
- Atherosclerotic Plaque
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 27 Oct 2021 (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.
Although advances in knowledge of the prevention, diagnosis and treatment of atherothrombosis are encouraging, cardiovascular diseases (CVD), with acute and chronic ischemic heart disease in particular, remain a major cause of disability and premature death throughout the world.
Cardiac rehabilitation (CR) and secondary prevention are coordinated multidimensional evidence-based strategies that aim to assist patients with acute and chronic ischemic heart disease return to an active and satisfying life and to prevent the recurrence of further cardiac events. Since CR is time limited after an acute event, secondary prevention proposes a continuum where care is provided for the rest of a person's life according to the existence of cardiovascular risk factors. Secondary prophylaxis is fundamental for the recovery of the patient, but in most cases, it is only insufficiently implemented.
To ensure adequate resources for the delivery of health care and to further improve the level of care, care-delivery models need to be changed in a way that patients themselves become more involved in their own care. Mobile health (mHealth) is a rapidly growing health delivery methodology with the potential to impact on health care research, health care delivery and health outcomes.
Therefore, the aim of the study is to determine the impact of plaque visualization using a digital intervention on treatment adherence to improve the cardiovascular risk profile. Participants will be randomized into two groups: intervention group and control group. Participants of the control group receive the best medical care according to current guideline recommendations without access to the app. Participants of the intervention group receive the best medical care according to current guideline recommendations with full access to the Smartphone application at time of study begin until the completion of the follow-up period of 12 months. The access to the app includes access to relevant findings including ultrasound images of the carotid artery, lipid profile, blood pressure values, and weight.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Patients receive the best medical care according to current guideline recommendations without access to the app |
| intervention group | Experimental | Other: PreventiPlaque AppPatients receive the best medical care according to current guideline recommendations with full access to the app. This includes access to relevant findings including ultrasound images of the carotid artery, lipid profile, blood pressure values, and weight. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ultrasound evidence of atherosclerotic plaque in one or both carotid arteries
- Own a smartphone and know how to use apps
- presumed life expectancy of more than one year
- willing to comply with the protocol and provide written informed consent
Key exclusion criteria (4 listed)
- congestive heart failure with NYHA (New York Heart Association classification) III-IV symptoms
- severe valve disease
- no german knowledge
- unwillingness to user the app and/or undergo diagnostic procedures
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 |
|---|---|---|
| PreventiPlaque AppPreventiPlaque is an app that supports patients with atherosclerotic plaque by strengthening their adherence. | Other | intervention group |
Primary outcome
Change in cardiovascular risk profile
Time frame: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
Measured via SCORE2 (Systematic Coronary Risk Evaluation) risk calculator
8 secondary outcomes
Change in LifeSimple7-Score
Time frame: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
Change in LDL-cholesterol
Time frame: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
Change in body weight
Time frame: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
Change in blood pressure
Time frame: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
Reported physical activity
Time frame: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
Change in cigarette dependency
Time frame: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
Change in reported medication adherence
Time frame: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
Satisfaction with outpatient care
Time frame: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Derived from this study: PubMed 39843925Ullrich G, Bauerle A, Jahre LM, Paldan K, Rosemeyer J, Kalaitzidis C, Rammos C, Teufel M, Rassaf T, Lortz J. Impact of visual presentation of atherosclerotic carotid plaque on cardiovascular risk profile using mHealth technologies. NPJ Digit Med. 2025 Jan 22;8(1):47. doi: 10.1038/s41746-024-01423-y.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PreventiPlaque App in people with Atherosclerotic Plaque, run by University Hospital, Essen.
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 4 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: status not confirmed, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Change in cardiovascular risk profile (time frame: baseline, 3 months follow-up, 6 months follow-up, 9 month follow-up, end of study after 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05096637, which also lists 1 linked publication.
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 27 Oct 2021.