Autoimmune DiseasesNCT02510092
Coronary Artery and Systemic Autoimmune Disease: Diagnostics and Treatment
A study testing Percutaneous coronary intervention with new generation fully resorbable scaffold in people with Autoimmune Diseases and Coronary Artery Disease, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.
Trial summary
This study evaluates in vivo intracoronary imaging using intravascular ultrasound and optical coherence tomography and safety and efficacy of new generation fully bioresorbable vascular scaffolds in four well defined systemic autoimmune (rheumatoid arthritis, mixed connective tissue disease, systemic sclerosis… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Autoimmune Diseases, Coronary Artery Disease
- What is being tested?
- Percutaneous coronary intervention with new generation fully resorbable scaffold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteHungary
- Study dates
- Jul 2015to Mar 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18+ years
- Signed and dated informed consent form
- Manifest autoimmune disease, consisting either of: rheumatoid arthritis or systemic lupus erythematosus or systemic sclerosis or mixed connective tissue disease under the care of a clinical immunologist
- Clinical indication for a coronary angiography as determined by a cardiologist
Who cannot join
- Age of 75+ years
- Glomerular filtration rate of under 30 ml/min
- Severely decreased left ventricular function (ejection fraction <35%)
- Pregnancy or nursing
- Unclear immunological diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Vivo Intravascular Diagnostics and Evaluation of New Therapeutic Modalities in Systemic Autoimmune and Coronary Artery Disease Patients
This study evaluates in vivo intracoronary imaging using intravascular ultrasound and optical coherence tomography and safety and efficacy of new generation fully bioresorbable vascular scaffolds in four well defined systemic autoimmune (rheumatoid arthritis, mixed connective tissue disease, systemic sclerosis, systemic lupus erythematosus) and concomitant coronary disease patients.
Read the detailed description
The aim of this study is to assess in vivo intracoronary anatomy using intravascular ultrasound and optical coherence tomography and assess the efficacy and safety of new generation fully bioresorbable vascular scaffolds in a systemic autoimmune and coronary heart disease patient population.
The following four well defined systemic autoimmune entities are linked to increased cardiovascular risk: rheumatoid arthritis, mixed connective tissue disease, systemic sclerosis and systemic lupus erythematosus. One of the main causes of death in systemic autoimmune subjects is cardiovascular disease. In-vivo intracoronary anatomy and pathology regarding systemic autoimmune diseases is unknown. Furthermore, all forms of revascularization in such patients yield sub-optimal results, with poor outcomes using even the most modern drug eluting metallic stents. This may be linked to a long term exaggerated chronic inflammation response to the metallic components. Thus, fully bioresorbable vascular scaffolds may prove more efficacious in systemic autoimmune subjects.
- Conditions
- Autoimmune Diseases, Coronary Artery Disease
- Being tested
- Percutaneous coronary intervention with new generation fully resorbable scaffold
- Medical subject headings
- Autoimmune Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary intervention with new generation fully resorbable scaffoldDevice
| Study group | Role | What they receive |
|---|---|---|
| Coronary artery diseae with revascularization indicated | Active comparator | Subjects with coronary artery disease, that require and are eligible for percutaneous revascularization. Receives: Device: Percutaneous coronary intervention with new generation fully resorbable scaffold |
| Coronary artery disease not requiring revascularization | No intervention | Subjects with coronary artery disease that do not require revascularization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac and cerebral events
Eligible for patients in clinical need for revascularization undergoing percutaneous revascularization with a bioresorbable vascular scaffold
Measured: From index procedure to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionMar 2021
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University Heart and Vascular Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Debrecen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510092
- Sponsor's protocol ID
- Im-CAD-001
- Status last verified
- Apr 2021
- First submitted
- 23 Jul 2015
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Intravascular Diagnostics and Evaluation of New Therapeutic Modalities in Systemic Autoimmune and Coronary Artery Disease Patients
- ClinicalTrials.gov ID
- NCT02510092
- Acronym / sponsor ID
- Im-CAD-001
- Conditions
- Autoimmune Diseases, Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Semmelweis University Heart and Vascular CenterUniversity, hospital or other
- Collaborators
- University of Debrecen
- Study start
- Jul 2015
- Primary completion
- Mar 2021 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 28 Jul 2015 (estimated)
- 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.
This study evaluates in vivo intracoronary imaging using intravascular ultrasound and optical coherence tomography and safety and efficacy of new generation fully bioresorbable vascular scaffolds in four well defined systemic autoimmune (rheumatoid arthritis, mixed connective tissue disease, systemic sclerosis, systemic lupus erythematosus) and concomitant coronary disease patients.
Detailed description
The aim of this study is to assess in vivo intracoronary anatomy using intravascular ultrasound and optical coherence tomography and assess the efficacy and safety of new generation fully bioresorbable vascular scaffolds in a systemic autoimmune and coronary heart disease patient population.
The following four well defined systemic autoimmune entities are linked to increased cardiovascular risk: rheumatoid arthritis, mixed connective tissue disease, systemic sclerosis and systemic lupus erythematosus. One of the main causes of death in systemic autoimmune subjects is cardiovascular disease. In-vivo intracoronary anatomy and pathology regarding systemic autoimmune diseases is unknown. Furthermore, all forms of revascularization in such patients yield sub-optimal results, with poor outcomes using even the most modern drug eluting metallic stents. This may be linked to a long term exaggerated chronic inflammation response to the metallic components. Thus, fully bioresorbable vascular scaffolds may prove more efficacious in systemic autoimmune subjects.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coronary artery diseae with revascularization indicated | Active comparator | Device: Percutaneous coronary intervention with new generation fully resorbable scaffoldSubjects with coronary artery disease, that require and are eligible for percutaneous revascularization. |
| Coronary artery disease not requiring revascularization | No intervention | –Subjects with coronary artery disease that do not require revascularization. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age of 18+ years
- Signed and dated informed consent form
- Manifest autoimmune disease, consisting either of: rheumatoid arthritis or systemic lupus erythematosus or systemic sclerosis or mixed connective tissue disease under the care of a clinical immunologist
- Clinical indication for a coronary angiography as determined by a cardiologist
Key exclusion criteria (5 listed)
- Age of 75+ years
- Glomerular filtration rate of under 30 ml/min
- Severely decreased left ventricular function (ejection fraction <35%)
- Pregnancy or nursing
- Unclear immunological diagnosis
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 |
|---|---|---|
| Percutaneous coronary intervention with new generation fully resorbable scaffold | Device | Coronary artery diseae with revascularization indicated |
Primary outcome
Major adverse cardiac and cerebral events
Time frame: From index procedure to 5 years
Eligible for patients in clinical need for revascularization undergoing percutaneous revascularization with a bioresorbable vascular scaffold
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 23 Apr 2021.
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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?
A study testing Percutaneous coronary intervention with new generation fully resorbable scaffold in people with Autoimmune Diseases and Coronary Artery Disease, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.
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 5 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 23 Apr 2021. 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 Hungary. 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?
Major adverse cardiac and cerebral events (time frame: From index procedure to 5 years). 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 23 Apr 2021.