Transplant; Failure, HeartIMPROVE-OCTNCT03079791
Impact of Level and Quality of Immunosuppression on Onset and Pattern of Cardiac Allograft Vasculopathy Evaluated by OCT
An observational study of Transplant; Failure, Heart, run by LMU Klinikum at 1 site in Germany.
Trial summary
The aim of this study is to use the high resolution of optical coherence tomography to assess the prevalence of different types of cardiac allograft vasculopathy (CAV) in cardiac transplanted patients and correlate those results with the level of immunosuppression Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant; Failure, Heart
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2016to Jan 2023
- How long will I take part?
- 2 Years
- 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: Patients after successful cardiac transplantation at the time of coronary angiography as part of routine follow-up after cardiac transplantation or as invasive diagnostic tool in case of clinical suspicion of cardiac allograft vasculopathy and indication for intravascular imaging according to guidelines.
Who may be able to join
- Patients after cardiac transplantation undergoing planed routine angiographic examination and intracoronary imaging.
- Written informed consent
Who cannot join
- Age < 18 years old
- Hemodynamic and/or electric instability
- Chronic kidney failure with glomerular filtration rate < 30 ml/min
- Pregnant or breastfeeding women
- Incapacity of providing informed consent
- If in the investigator's opinion the patient has (a) co-morbid condition(s) that could limit the patient's ability to participate in the study or impact the scientific integrity of the study
- Any contraindication to intracoronary imaging
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Registry of Impact of Level and Quality of Immunosuppression on Onset and Pattern of Cardiac Allograft Vasculopathy Evaluated by OCT.
The aim of this study is to use the high resolution of optical coherence tomography to assess the prevalence of different types of cardiac allograft vasculopathy (CAV) in cardiac transplanted patients and correlate those results with the level of immunosuppression
Read the detailed description
CAV is the most common reason for retransplantation at >1 year and one of the main risk factors for mortality after cardiac transplantation. For this registry, patients planned to undergo coronary angiography either as a part of routine follow-up to screen for relevant cardiac allograft vasculopathy or because of clinical suspicion of relevant cardiac allograft vasculopathy will be considered eligible.
Since the "Transplant Care Guidelines of 2010" recommend the use of intracoronary imaging during angiographic follow-up in patients after heart transplantation to recognize CAV as early as possible, OCT has become integral part of the CAV diagnostic in our center. Through its high resolution OCT (so called virtual histology) provides the earliest possible diagnosis of CAV as well as new insights into the differentiation of CAV types. We aim to correlate the findings of OCT with the level of immunosuppression.
- Conditions
- Transplant; Failure, Heart
- Keywords
- OCT, cardiac allograft vasculopathy, CAV, intravascular imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
CAV patterns
Evaluation of CAV with optical coherence tomography imaging in different follow-up timepoints according to the Heart Transplant Care guidelines
Measured: 2 years
Secondary outcomes (2)
Immunosuppression compliance
Association between pattern of CAV and the appropriateness of immunosuppression as measured regularly in routine laboratory
Measured: 2 years
combined ischemic events
Combined incidence of death, re-transplantation, myocardial infarction, stroke and coronary revascularization
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study startJul 2016
- Primary completionJan 2023
- Study completionJan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant; Failure, HeartStudies 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
- 100 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steffen Massberg, LMU Klinikum
- Investigators
- Steffen Massberg, MD, Principal investigator, LMU Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079791
- Sponsor's protocol ID
- GE MucI001-16
- Acronym
- IMPROVE-OCT
- Status last verified
- May 2023
- First submitted
- 27 Jul 2016
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry of Impact of Level and Quality of Immunosuppression on Onset and Pattern of Cardiac Allograft Vasculopathy Evaluated by OCT.
- ClinicalTrials.gov ID
- NCT03079791
- Acronym / sponsor ID
- IMPROVE-OCT / GE MucI001-16
- Conditions
- Transplant; Failure, Heart
- Keywords
- OCT, cardiac allograft vasculopathy, CAV, intravascular imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Jan 2023 (actual)
- Study completion
- Jan 2023 (actual)
- First posted
- 14 Mar 2017 (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.
The aim of this study is to use the high resolution of optical coherence tomography to assess the prevalence of different types of cardiac allograft vasculopathy (CAV) in cardiac transplanted patients and correlate those results with the level of immunosuppression
Detailed description
CAV is the most common reason for retransplantation at >1 year and one of the main risk factors for mortality after cardiac transplantation. For this registry, patients planned to undergo coronary angiography either as a part of routine follow-up to screen for relevant cardiac allograft vasculopathy or because of clinical suspicion of relevant cardiac allograft vasculopathy will be considered eligible.
Since the "Transplant Care Guidelines of 2010" recommend the use of intracoronary imaging during angiographic follow-up in patients after heart transplantation to recognize CAV as early as possible, OCT has become integral part of the CAV diagnostic in our center. Through its high resolution OCT (so called virtual histology) provides the earliest possible diagnosis of CAV as well as new insights into the differentiation of CAV types. We aim to correlate the findings of OCT with the level of immunosuppression.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after successful cardiac transplantation at the time of coronary angiography as part of routine follow-up after cardiac transplantation or as invasive diagnostic tool in case of clinical suspicion of cardiac allograft vasculopathy and indication for intravascular imaging according to guidelines.
Key inclusion criteria (2 listed)
- Patients after cardiac transplantation undergoing planed routine angiographic examination and intracoronary imaging.
- Written informed consent
Key exclusion criteria (7 listed)
- Age < 18 years old
- Hemodynamic and/or electric instability
- Chronic kidney failure with glomerular filtration rate < 30 ml/min
- Pregnant or breastfeeding women
- Incapacity of providing informed consent
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
CAV patterns
Time frame: 2 years
Evaluation of CAV with optical coherence tomography imaging in different follow-up timepoints according to the Heart Transplant Care guidelines
2 secondary outcomes
Immunosuppression compliance
Time frame: 2 years
combined ischemic events
Time frame: 2 years
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 9 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
Steffen Massberg, MD principal investigator
LMU Munich
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 Transplant; Failure, Heart, run by LMU Klinikum 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 2 inclusion and 7 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 9 May 2023. 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?
CAV patterns (time frame: 2 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 9 May 2023.