Cardiac Allograft VasculopathyNCT02777255
Severe CAV MRI in Heart Transplant Recipient
An observational study of Cardiac Allograft Vasculopathy, run by University of Minnesota at 1 site in United States.
Trial summary
Hypothesis: CAV is associated with fibrotic changes on cardiac MRI, altered levels of pathogenetically-related biomarkers, and specific RNA expression changes in the blood Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Allograft Vasculopathy
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Dec 2014
- 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: Heart transplant patients with severe CAV and heart transplant patients without CAV
Who may be able to join
- Age ≥ 18 years
- Provide informed consent
- Successful orthotopic heart transplant within 15 years of enrollment
Who cannot join
- Chronic kidney disease with creatinine >2.5 mg/dl
- Ejection fraction <45% if CAV or <50% if no CAV
- IV contrast allergy or reaction (gadolinium)
- Active infection (febrile illness, cytomegalovirus or other significant infection)
- Treated humoral rejection or cellular rejection grade 3A/2R or greater within 3 months
- Contraindication to MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
About this study
Official title: Evaluation of Genomic, Structural and Molecular Changes Associated With Severe Cardiac Allograft Vasculopathy in Heart Transplant Recipients
Hypothesis: CAV is associated with fibrotic changes on cardiac MRI, altered levels of pathogenetically-related biomarkers, and specific RNA expression changes in the blood
Read the detailed description
Cardiac allograft vasculopathy (CAV) is a major limitation to longevity after heart transplantation (HT), accounting for almost 30% of deaths after year 5. The only cure is re-transplant which is associated with a 30-day mortality of 30%, and raises ethical issues due to limited resources. Standard preventive measures, such as statin therapy, have limited success due to the multi-factorial nature of the process and influence of transplant-specific risk factors. Consensus regarding the management of CAV is lacking due to the absence of prospective studies evaluating timing of initiation of therapy, effect of therapies on long-term outcomes, and effective diagnostic strategies. Primary prevention of CAV, which will be evaluated in the proposed study, could improve longevity of heart transplant recipients and optimize use of a limited resource.
The current gold standard for evaluation of CAV is surveillance coronary angiogram, which is highly insensitive, particularly in early disease. Intravascular ultrasound (IVUS) is the most sensitive tool for the diagnosis of CAV, providing specific information such as the appearance and thickness of the intima and media, however it is not widely used in the clinical setting. Physiologic studies of the coronary arteries are also useful in assessing risk, but are not practical in a clinical setting. These invasive studies expose the heart transplant recipient to radiation, nephrotoxic contrast, and potential vascular complications. During the evolution of CAV, there are important structural, functional, and genomic changes that occur in parallel and possibly before.
Study Objectives
- Determine the structural, functional and genomic changes associated with severe CAV
- Identify novel and noninvasive markers of CAV
Study Design This is a cross-sectional study which will evaluate structural, functional and genomic changes associated with severe CAV in heart transplant recipients within 15 years of transplant. 30 heart transplant recipients identified via our study database and the transplant clinic will be enrolled into the study. We will enroll 15 heart transplant patients with severe CAV and 15 without CAV.
Subjects will undergo a one-time assessment of radial artery elasticity, blood draw for gene expression profiles, and cardiac MRI.
- Conditions
- Cardiac Allograft Vasculopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline associated with severe CAV
Determine the structural (degree of fibrosis), functional and genomic changes associated with severe CAV
Measured: 1 year
Secondary outcomes (1)
Novel noninvasive markers of CAV from baseline
Identify novel and noninvasive markers of CAV
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startMay 2012
- Primary completionMay 2014
- Study completionDec 2014
Why it stopped: PI left University
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Allograft VasculopathyStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monica M Colvin-Adams, MD.,MS, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777255
- Sponsor's protocol ID
- 1103M96798
- Status last verified
- May 2016
- First submitted
- 13 Mar 2013
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Genomic, Structural and Molecular Changes Associated With Severe Cardiac Allograft Vasculopathy in Heart Transplant Recipients
- ClinicalTrials.gov ID
- NCT02777255
- Acronym / sponsor ID
- 1103M96798
- Conditions
- Cardiac Allograft Vasculopathy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI left University
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 19 May 2016 (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.
Hypothesis: CAV is associated with fibrotic changes on cardiac MRI, altered levels of pathogenetically-related biomarkers, and specific RNA expression changes in the blood
Detailed description
Cardiac allograft vasculopathy (CAV) is a major limitation to longevity after heart transplantation (HT), accounting for almost 30% of deaths after year 5. The only cure is re-transplant which is associated with a 30-day mortality of 30%, and raises ethical issues due to limited resources. Standard preventive measures, such as statin therapy, have limited success due to the multi-factorial nature of the process and influence of transplant-specific risk factors. Consensus regarding the management of CAV is lacking due to the absence of prospective studies evaluating timing of initiation of therapy, effect of therapies on long-term outcomes, and effective diagnostic strategies. Primary prevention of CAV, which will be evaluated in the proposed study, could improve longevity of heart transplant recipients and optimize use of a limited resource.
The current gold standard for evaluation of CAV is surveillance coronary angiogram, which is highly insensitive, particularly in early disease. Intravascular ultrasound (IVUS) is the most sensitive tool for the diagnosis of CAV, providing specific information such as the appearance and thickness of the intima and media, however it is not widely used in the clinical setting. Physiologic studies of the coronary arteries are also useful in assessing risk, but are not practical in a clinical setting. These invasive studies expose the heart transplant recipient to radiation, nephrotoxic contrast, and potential vascular complications. During the evolution of CAV, there are important structural, functional, and genomic changes that occur in parallel and possibly before.
Study Objectives
- Determine the structural, functional and genomic changes associated with severe CAV
- Identify novel and noninvasive markers of CAV
Study Design This is a cross-sectional study which will evaluate structural, functional and genomic changes associated with severe CAV in heart transplant recipients within 15 years of transplant. 30 heart transplant recipients identified via our study database and the transplant clinic will be enrolled into the study. We will enroll 15 heart transplant patients with severe CAV and 15 without CAV.
Subjects will undergo a one-time assessment of radial artery elasticity, blood draw for gene expression profiles, and cardiac MRI.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart transplant patients with severe CAV and heart transplant patients without CAV
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Provide informed consent
- Successful orthotopic heart transplant within 15 years of enrollment
Key exclusion criteria (6 listed)
- Chronic kidney disease with creatinine >2.5 mg/dl
- Ejection fraction <45% if CAV or <50% if no CAV
- IV contrast allergy or reaction (gadolinium)
- Active infection (febrile illness, cytomegalovirus or other significant infection)
- Treated humoral rejection or cellular rejection grade 3A/2R or greater within 3 months
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
Changes from baseline associated with severe CAV
Time frame: 1 year
Determine the structural (degree of fibrosis), functional and genomic changes associated with severe CAV
1 secondary outcome
Novel noninvasive markers of CAV from baseline
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
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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.
Monica M Colvin-Adams, MD.,MS principal investigator
University of Minnesota
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 Cardiac Allograft Vasculopathy, run by University of Minnesota at 1 site in United States.
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 6 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: withdrawn, as of the sponsor's last update on 19 May 2016. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Changes from baseline associated with severe CAV (time frame: 1 year). 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 19 May 2016.