Cardiac Allograft VasculopathySTOPCAVNCT01305395
Strategies To Prevent Cardiac Allograft Vasculopathy Related Events in Heart Transplant Recipients
A study testing Sirolimus in people with Cardiac Allograft Vasculopathy, run by University of Minnesota at 1 site in United States.
Trial summary
1. Early initiation of sirolimus will prevent or delay the development of intimal thickening and subsequent graft failure. 2. Treatment guided by the development of cardiac allograft vasculopathy (CAV) on intravascular ultrasound (IVUS) will be more effective in delaying progression of CAV compared to treatment guided… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Allograft Vasculopathy
- What is being tested?
- Sirolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jan 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For Prospective Arm:
- 18 years or older
- Successful orthotropic heart transplant within 6 months of enrollment
- For Retrospective Arm:
- 18 years or older
- Successful orthotropic heart transplant within 6 months to 3 years of enrolment
- Less than moderate CAV by angiogram or IVUS
Who cannot join
- For Prospective Arm:
- Greater than minimal baseline coronary disease
- Chronic kidney disease with creatinine >2mg/dl
- Baseline (1 month) ejection fraction < 50%
- IV contrast allergy
- Rejection within 3 months of enrollment
Show all 16Show fewer
- Sensitivity to sirolimus or its derivatives
- Prior sirolimus use
- For Retrospective Arm:
- Significant baseline (one month) coronary artery disease (>50% in one or more vessels by angiogram or MIT >0.5 by IVUS)
- Chronic kidney disease with creatinine >2mg/dl
- Baseline (1 month) ejection fraction < 50%
- IV contrast allergy
- Rejection within 3 months prior to enrollment
- Sensitivity to sirolimus or its derivatives
- Prior sirolimus use
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardiology Division, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Early Vs Late Sirolimus-Initiation Strategies To Prevent Cardiac Allograft Vasculopathy Related Events in Heart Transplant Recipients
- Early initiation of sirolimus will prevent or delay the development of intimal thickening and subsequent graft failure.
- Treatment guided by the development of cardiac allograft vasculopathy (CAV) on intravascular ultrasound (IVUS) will be more effective in delaying progression of CAV compared to treatment guided by angiography.
- Prevention of the development and progression of intimal thickness on IVUS will prevent the development of heart failure, graft dysfunction, and cardiovascular death related to CAV.
- Small artery elasticity predicts progression of cardiac allograft vasculopathy and is modified by sirolimus
- Patients who have no progression of CAV will have favorable improvement in biomarkers and endothelial cells compared to patients who have progression of CAV
Read the detailed description
Proliferation signal inhibitors (PSIs), sirolimus and everolimus, have been demonstrated to be effective immunosuppressants and delay the progression of cardiac allograft vasculopathy. To date, there are no prospective studies designed to evaluate the potential use of PSIs as a primary immunosuppressant in the prevention of cardiac allograft vasculopathy. The goals of our study are to compare primary vs. secondary preventive strategies and to evaluate the role of intravascular ultrasound compared to coronary angiogram in diagnosing CAV and preventing CAV-related events. The specific aims of the study are:
- To evaluate the effect of primary vs. secondary initiation of sirolimus on the development of significant coronary artery (> 70% angiographic stenosis, Mean intimal thickness (MIT) 0.5mm or greater, IVUS calculated coronary cross sectional area of < 4mm2 / <6mm2 for mid LAD/Left Maim (LM), < 0.75 fractional flow reserve (FFR) lesion associated with a positive stress test), change in global left ventricle (LV) function, incidence of rejection episodes, and hospitalizations at 1, 2, 3, and 4 years.
- To determine the effect of IVUS-guided initiation of sirolimus on short-term and long-term outcomes vs. angiogram-guided initiation of sirolimus
- To determine whether prevention of progression of CAV diagnosed by IVUS prevents graft dysfunction or death related to CAV or heart failure.
- To assess the correlation between peripheral small artery elasticity, peripheral biomarkers, and endothelial cells, and development of cardiac allograft vasculopathy in order to develop a strategy for determining risk of progression and monitoring treatment.
The study has a prospective and a retrospective arm
Prospective Arm Design: This is a prospective, randomized, partially-blinded pilot study. Randomization for the study will be done in 2 stages.
The first stage of randomization will randomize subjects to either the early or late initiation of sirolimus. At this stage of the randomization, subject will have a 30% chance of being in group 1 (early-initiation of sirolimus), and a 70% chance of being in group 2 (diagnostic-guided sirolimus group).
The second stage randomization will be done only on subjects in group 2 (diagnostic-guided sirolimus group) at the time of their first annual heart transplant review. At the time of their annual heart transplant review, subjects in group 2 will have a 50% chance of being in group 2A (CAV diagnosed by angiogram), and a 50% chance of being in group 2B (CAV diagnosed by intravascular ultrasound).
Group 1: Initiate sirolimus at 6 months after transplant
Group 2A: Initiate sirolimus after development of angiographic stenosis of >70% in a major epicardial vessel or >50% in the left main artery
Group 2B: Initiate sirolimus after development of maximal intimal thickness of 0.5 mm on intravascular ultrasound
Retrospective Arm
The main objective of this retrospective study is to compare a treatment strategy based on the diagnosis of CAV by intravascular ultrasound to a strategy guided by angiogram.
Design: This is a randomized, partially-blinded pilot study. Subjects will be randomized 1:1 to one of two groups. At the time of the randomization, the subject will have a 50% chance of being in group 1 (initiation of sirolimus when CAV is diagnosed by angiogram) and a 50% chance of being in group 2. (Initiation of sirolimus when CAV is diagnosed by IVUS)
Primary Endpoints for Prospective and Retrospective Arms
- Change in maximal intimal thickness at 1, 2, 3 and 4 years
- Combination of significant coronary artery disease (as described above), death, major rejection episodes, and decrease in global ejection function of more than 10% from baseline at 3 and 4years.
Secondary endpoints for Prospective and Retrospective Arms
- Mean MIT at 1, 2, 3, and 4 years
- Percent atheroma volume at 1,2,3 and 4 years
- Death from CAV, death from any cause, myocardial infarction, need for PCI, number of hospitalizations, infection rates, evidence of restrictive physiology, arrhythmic event related to CAV or pulmonary hypertension at 4 years.
- Change in small artery elasticity at 1, 2, 3, and 4 years
- Change in endothelial progenitor cell count at 1 and 2 years
- Change in biomarkers (see table) at 1 and 2 years
- Conditions
- Cardiac Allograft Vasculopathy
- Being tested
- Sirolimus
- Keywords
- Cardiac Allograft Vasculopathy in Heart Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SirolimusDrug
Also called Rapamycin
Will initiate sirolimus within 6 months of heart transplant
SirolimusDrug
Also called Rapamycin
Will start sirolimus after CAV has been diagnosed by angiogram
SirolimusDrug
Also called Rapamycin
Will start sirolimus after CAV has been diagnosed by intravascular ultrasound
SirolimusDrug
Also called Rapamycin
Will start sirolimus after they develop CAV by angiogram
SirolimusDrug
Also called Rapamycin
Will start sirolimus after CAV has been diagnosed by intravascular ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Early Intervention Arm | Experimental | Initiate sirolimus within 6 months of heart transplant Receives: Drug: Sirolimus |
| Late Intervention Arm: Group 2A | Experimental | Initiate sirolimus after CAV is diagnosed by angiogram Receives: Drug: Sirolimus |
| Retrospective Arm: Angiogram group | Experimental | Start sirolimus after CAV diagnosed is by angiogram Receives: Drug: Sirolimus |
| Late Intervention Arm: Group 2B | Experimental | Start sirolimus after CAV is diagnosed by IVUS Receives: Drug: Sirolimus |
| Retrospective Arm: Intravascular Ultrasound | Experimental | Sirolimus after CAV is diagnosed by IVUS Receives: Drug: Sirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Change in maximal intimal thickness
Measured: 1, 2, 3 and 4 years
Secondary outcomes (6)
Mean maximal intima thickness
Measured: 1, 2, 3, and 4 years
Percent atheroma volume
Measured: 1,2,3 and 4 years
Death from CAV, death from any cause, myocardial infarction, need for percutaneous coronary intervention (PCI), number of hospitalizations, infection rates, evidence of restrictive physiology, arrhythmic event related to CAV or pulmonary hypertension
Measured: at 4 years.
Change in small artery elasticity
Measured: At 1, 2, 3, and 4 years
Change in endothelial progenitor cell count
Measured: At 1 and 2 years
Change in biomarkers
Measured: At 1 and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2011 (estimated)
- Study startNov 2010
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: Due in part, to reduced transplant volume and enrollment has been difficult.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- 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
- NCT01305395
- Sponsor's protocol ID
- 1007M85473
- Acronym
- STOPCAV
- Status last verified
- Jan 2017
- First submitted
- 25 Feb 2011
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Christie JD, Edwards LB, Aurora P, Dobbels F, Kirk R, Rahmel AO, Stehlik J, Taylor DO, Kucheryavaya AY, Hertz MI. The Registry of the International Society for Heart and Lung Transplantation: Twenty-sixth Official Adult Lung and Heart-Lung Transplantation Report-2009. J Heart Lung Transplant. 2009 Oct;28(10):1031-49. doi: 10.1016/j.healun.2009.08.004. No abstract available.
PubMed 19782285Rahmani M, Cruz RP, Granville DJ, McManus BM. Allograft vasculopathy versus atherosclerosis. Circ Res. 2006 Oct 13;99(8):801-15. doi: 10.1161/01.RES.0000246086.93555.f3.
PubMed 17038650Weis M, von Scheidt W. Cardiac allograft vasculopathy: a review. Circulation. 1997 Sep 16;96(6):2069-77. doi: 10.1161/01.cir.96.6.2069.
PubMed 9323100Johnson DE, Alderman EL, Schroeder JS, Gao SZ, Hunt S, DeCampli WM, Stinson E, Billingham M. Transplant coronary artery disease: histopathologic correlations with angiographic morphology. J Am Coll Cardiol. 1991 Feb;17(2):449-57. doi: 10.1016/s0735-1097(10)80114-7.
PubMed 1991903Rickenbacher PR, Pinto FJ, Chenzbraun A, Botas J, Lewis NP, Alderman EL, Valantine HA, Hunt SA, Schroeder JS, Popp RL, et al. Incidence and severity of transplant coronary artery disease early and up to 15 years after transplantation as detected by intravascular ultrasound. J Am Coll Cardiol. 1995 Jan;25(1):171-7. doi: 10.1016/0735-1097(94)00323-i.
PubMed 7798497Costello JM, Wax DF, Binns HJ, Backer CL, Mavroudis C, Pahl E. A comparison of intravascular ultrasound with coronary angiography for evaluation of transplant coronary disease in pediatric heart transplant recipients. J Heart Lung Transplant. 2003 Jan;22(1):44-9. doi: 10.1016/s1053-2498(02)00484-9.
PubMed 12531412Sharples LD, Jackson CH, Parameshwar J, Wallwork J, Large SR. Diagnostic accuracy of coronary angiography and risk factors for post-heart-transplant cardiac allograft vasculopathy. Transplantation. 2003 Aug 27;76(4):679-82. doi: 10.1097/01.TP.0000071200.37399.1D.
PubMed 12973108Kobashigawa JA, Tobis JM, Starling RC, Tuzcu EM, Smith AL, Valantine HA, Yeung AC, Mehra MR, Anzai H, Oeser BT, Abeywickrama KH, Murphy J, Cretin N. Multicenter intravascular ultrasound validation study among heart transplant recipients: outcomes after five years. J Am Coll Cardiol. 2005 May 3;45(9):1532-7. doi: 10.1016/j.jacc.2005.02.035.
PubMed 15862430Tuzcu EM, Kapadia SR, Sachar R, Ziada KM, Crowe TD, Feng J, Magyar WA, Hobbs RE, Starling RC, Young JB, McCarthy P, Nissen SE. Intravascular ultrasound evidence of angiographically silent progression in coronary atherosclerosis predicts long-term morbidity and mortality after cardiac transplantation. J Am Coll Cardiol. 2005 May 3;45(9):1538-42. doi: 10.1016/j.jacc.2004.12.076.
PubMed 15862431Mancini D, Pinney S, Burkhoff D, LaManca J, Itescu S, Burke E, Edwards N, Oz M, Marks AR. Use of rapamycin slows progression of cardiac transplantation vasculopathy. Circulation. 2003 Jul 8;108(1):48-53. doi: 10.1161/01.CIR.0000070421.38604.2B. Epub 2003 May 12.
PubMed 12742978Keogh A, Richardson M, Ruygrok P, Spratt P, Galbraith A, O'Driscoll G, Macdonald P, Esmore D, Muller D, Faddy S. Sirolimus in de novo heart transplant recipients reduces acute rejection and prevents coronary artery disease at 2 years: a randomized clinical trial. Circulation. 2004 Oct 26;110(17):2694-700. doi: 10.1161/01.CIR.0000136812.90177.94. Epub 2004 Jul 19.
PubMed 15262845Raichlin E, Bae JH, Khalpey Z, Edwards BS, Kremers WK, Clavell AL, Rodeheffer RJ, Frantz RP, Rihal C, Lerman A, Kushwaha SS. Conversion to sirolimus as primary immunosuppression attenuates the progression of allograft vasculopathy after cardiac transplantation. Circulation. 2007 Dec 4;116(23):2726-33. doi: 10.1161/CIRCULATIONAHA.107.692996. Epub 2007 Nov 19.
PubMed 18025531Raichlin E, Prasad A, Kremers WK, Edwards BS, Rihal CS, Lerman A, Kushwaha SS. Sirolimus as primary immunosuppression is associated with improved coronary vasomotor function compared with calcineurin inhibitors in stable cardiac transplant recipients. Eur Heart J. 2009 Jun;30(11):1356-63. doi: 10.1093/eurheartj/ehp123. Epub 2009 Apr 21.
PubMed 19383734
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Vs Late Sirolimus-Initiation Strategies To Prevent Cardiac Allograft Vasculopathy Related Events in Heart Transplant Recipients
- ClinicalTrials.gov ID
- NCT01305395
- Acronym / sponsor ID
- STOPCAV / 1007M85473
- Conditions
- Cardiac Allograft Vasculopathy
- Keywords
- Cardiac Allograft Vasculopathy in Heart Transplant
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due in part, to reduced transplant volume and enrollment has been difficult.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 28 Feb 2011 (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.
- Early initiation of sirolimus will prevent or delay the development of intimal thickening and subsequent graft failure.
- Treatment guided by the development of cardiac allograft vasculopathy (CAV) on intravascular ultrasound (IVUS) will be more effective in delaying progression of CAV compared to treatment guided by angiography.
- Prevention of the development and progression of intimal thickness on IVUS will prevent the development of heart failure, graft dysfunction, and cardiovascular death related to CAV.
- Small artery elasticity predicts progression of cardiac allograft vasculopathy and is modified by sirolimus
- Patients who have no progression of CAV will have favorable improvement in biomarkers and endothelial cells compared to patients who have progression of CAV
Detailed description
Proliferation signal inhibitors (PSIs), sirolimus and everolimus, have been demonstrated to be effective immunosuppressants and delay the progression of cardiac allograft vasculopathy. To date, there are no prospective studies designed to evaluate the potential use of PSIs as a primary immunosuppressant in the prevention of cardiac allograft vasculopathy. The goals of our study are to compare primary vs. secondary preventive strategies and to evaluate the role of intravascular ultrasound compared to coronary angiogram in diagnosing CAV and preventing CAV-related events. The specific aims of the study are:
- To evaluate the effect of primary vs. secondary initiation of sirolimus on the development of significant coronary artery (> 70% angiographic stenosis, Mean intimal thickness (MIT) 0.5mm or greater, IVUS calculated coronary cross sectional area of < 4mm2 / <6mm2 for mid LAD/Left Maim (LM), < 0.75 fractional flow reserve (FFR) lesion associated with a positive stress test), change in global left ventricle (LV) function, incidence of rejection episodes, and hospitalizations at 1, 2, 3, and 4 years.
- To determine the effect of IVUS-guided initiation of sirolimus on short-term and long-term outcomes vs. angiogram-guided initiation of sirolimus
- To determine whether prevention of progression of CAV diagnosed by IVUS prevents graft dysfunction or death related to CAV or heart failure.
- To assess the correlation between peripheral small artery elasticity, peripheral biomarkers, and endothelial cells, and development of cardiac allograft vasculopathy in order to develop a strategy for determining risk of progression and monitoring treatment.
The study has a prospective and a retrospective arm
Prospective Arm Design: This is a prospective, randomized, partially-blinded pilot study. Randomization for the study will be done in 2 stages.
The first stage of randomization will randomize subjects to either the early or late initiation of sirolimus. At this stage of the randomization, subject will have a 30% chance of being in group 1 (early-initiation of sirolimus), and a 70% chance of being in group 2 (diagnostic-guided sirolimus group).
The second stage randomization will be done only on subjects in group 2 (diagnostic-guided sirolimus group) at the time of their first annual heart transplant review. At the time of their annual heart transplant review, subjects in group 2 will have a 50% chance of being in group 2A (CAV diagnosed by angiogram), and a 50% chance of being in group 2B (CAV diagnosed by intravascular ultrasound).
Group 1: Initiate sirolimus at 6 months after transplant
Group 2A: Initiate sirolimus after development of angiographic stenosis of >70% in a major epicardial vessel or >50% in the left main artery
Group 2B: Initiate sirolimus after development of maximal intimal thickness of 0.5 mm on intravascular ultrasound
Retrospective Arm
The main objective of this retrospective study is to compare a treatment strategy based on the diagnosis of CAV by intravascular ultrasound to a strategy guided by angiogram.
Design: This is a randomized, partially-blinded pilot study. Subjects will be randomized 1:1 to one of two groups. At the time of the randomization, the subject will have a 50% chance of being in group 1 (initiation of sirolimus when CAV is diagnosed by angiogram) and a 50% chance of being in group 2. (Initiation of sirolimus when CAV is diagnosed by IVUS)
Primary Endpoints for Prospective and Retrospective Arms
- Change in maximal intimal thickness at 1, 2, 3 and 4 years
- Combination of significant coronary artery disease (as described above), death, major rejection episodes, and decrease in global ejection function of more than 10% from baseline at 3 and 4years.
Secondary endpoints for Prospective and Retrospective Arms
- Mean MIT at 1, 2, 3, and 4 years
- Percent atheroma volume at 1,2,3 and 4 years
- Death from CAV, death from any cause, myocardial infarction, need for PCI, number of hospitalizations, infection rates, evidence of restrictive physiology, arrhythmic event related to CAV or pulmonary hypertension at 4 years.
- Change in small artery elasticity at 1, 2, 3, and 4 years
- Change in endothelial progenitor cell count at 1 and 2 years
- Change in biomarkers (see table) at 1 and 2 years
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Early Intervention Arm | Experimental | Drug: SirolimusInitiate sirolimus within 6 months of heart transplant |
| Late Intervention Arm: Group 2A | Experimental | Drug: SirolimusInitiate sirolimus after CAV is diagnosed by angiogram |
| Retrospective Arm: Angiogram group | Experimental | Drug: SirolimusStart sirolimus after CAV diagnosed is by angiogram |
| Late Intervention Arm: Group 2B | Experimental | Drug: SirolimusStart sirolimus after CAV is diagnosed by IVUS |
| Retrospective Arm: Intravascular Ultrasound | Experimental | Drug: SirolimusSirolimus after CAV is diagnosed by IVUS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years or older
- Successful orthotropic heart transplant within 6 months of enrollment
- 18 years or older
- Successful orthotropic heart transplant within 6 months to 3 years of enrolment
- Less than moderate CAV by angiogram or IVUS
Key exclusion criteria (16 listed)
- Greater than minimal baseline coronary disease
- Chronic kidney disease with creatinine >2mg/dl
- Baseline (1 month) ejection fraction < 50%
- IV contrast allergy
- Rejection within 3 months of enrollment
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 |
|---|---|---|
| SirolimusAlso: RapamycinWill initiate sirolimus within 6 months of heart transplant | Drug | Early Intervention Arm |
| SirolimusAlso: RapamycinWill start sirolimus after CAV has been diagnosed by angiogram | Drug | Late Intervention Arm: Group 2A |
| SirolimusAlso: RapamycinWill start sirolimus after CAV has been diagnosed by intravascular ultrasound | Drug | Late Intervention Arm: Group 2B |
| SirolimusAlso: RapamycinWill start sirolimus after they develop CAV by angiogram | Drug | Retrospective Arm: Angiogram group |
| SirolimusAlso: RapamycinWill start sirolimus after CAV has been diagnosed by intravascular ultrasound | Drug | Retrospective Arm: Intravascular Ultrasound |
Primary outcome
1. Change in maximal intimal thickness
Time frame: 1, 2, 3 and 4 years
6 secondary outcomes
Mean maximal intima thickness
Time frame: 1, 2, 3, and 4 years
Percent atheroma volume
Time frame: 1,2,3 and 4 years
Death from CAV, death from any cause, myocardial infarction, need for percutaneous coronary intervention (PCI), number of hospitalizations, infection rates, evidence of restrictive physiology, arrhythmic event related to CAV or pulmonary hypertension
Time frame: at 4 years.
Change in small artery elasticity
Time frame: At 1, 2, 3, and 4 years
Change in endothelial progenitor cell count
Time frame: At 1 and 2 years
Change in biomarkers
Time frame: At 1 and 2 years
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 24 Jan 2017.
- Background: PubMed 19782285Christie JD, Edwards LB, Aurora P, Dobbels F, Kirk R, Rahmel AO, Stehlik J, Taylor DO, Kucheryavaya AY, Hertz MI. The Registry of the International Society for Heart and Lung Transplantation: Twenty-sixth Official Adult Lung and Heart-Lung Transplantation Report-2009. J Heart Lung Transplant. 2009 Oct;28(10):1031-49. doi: 10.1016/j.healun.2009.08.004. No abstract available.
- Background: PubMed 17038650Rahmani M, Cruz RP, Granville DJ, McManus BM. Allograft vasculopathy versus atherosclerosis. Circ Res. 2006 Oct 13;99(8):801-15. doi: 10.1161/01.RES.0000246086.93555.f3.
- Background: PubMed 9323100Weis M, von Scheidt W. Cardiac allograft vasculopathy: a review. Circulation. 1997 Sep 16;96(6):2069-77. doi: 10.1161/01.cir.96.6.2069.
- Background: PubMed 1991903Johnson DE, Alderman EL, Schroeder JS, Gao SZ, Hunt S, DeCampli WM, Stinson E, Billingham M. Transplant coronary artery disease: histopathologic correlations with angiographic morphology. J Am Coll Cardiol. 1991 Feb;17(2):449-57. doi: 10.1016/s0735-1097(10)80114-7.
- Background: PubMed 7798497Rickenbacher PR, Pinto FJ, Chenzbraun A, Botas J, Lewis NP, Alderman EL, Valantine HA, Hunt SA, Schroeder JS, Popp RL, et al. Incidence and severity of transplant coronary artery disease early and up to 15 years after transplantation as detected by intravascular ultrasound. J Am Coll Cardiol. 1995 Jan;25(1):171-7. doi: 10.1016/0735-1097(94)00323-i.
- Background: PubMed 12531412Costello JM, Wax DF, Binns HJ, Backer CL, Mavroudis C, Pahl E. A comparison of intravascular ultrasound with coronary angiography for evaluation of transplant coronary disease in pediatric heart transplant recipients. J Heart Lung Transplant. 2003 Jan;22(1):44-9. doi: 10.1016/s1053-2498(02)00484-9.
- Background: PubMed 12973108Sharples LD, Jackson CH, Parameshwar J, Wallwork J, Large SR. Diagnostic accuracy of coronary angiography and risk factors for post-heart-transplant cardiac allograft vasculopathy. Transplantation. 2003 Aug 27;76(4):679-82. doi: 10.1097/01.TP.0000071200.37399.1D.
- Background: PubMed 15862430Kobashigawa JA, Tobis JM, Starling RC, Tuzcu EM, Smith AL, Valantine HA, Yeung AC, Mehra MR, Anzai H, Oeser BT, Abeywickrama KH, Murphy J, Cretin N. Multicenter intravascular ultrasound validation study among heart transplant recipients: outcomes after five years. J Am Coll Cardiol. 2005 May 3;45(9):1532-7. doi: 10.1016/j.jacc.2005.02.035.
- Background: PubMed 15862431Tuzcu EM, Kapadia SR, Sachar R, Ziada KM, Crowe TD, Feng J, Magyar WA, Hobbs RE, Starling RC, Young JB, McCarthy P, Nissen SE. Intravascular ultrasound evidence of angiographically silent progression in coronary atherosclerosis predicts long-term morbidity and mortality after cardiac transplantation. J Am Coll Cardiol. 2005 May 3;45(9):1538-42. doi: 10.1016/j.jacc.2004.12.076.
- Background: PubMed 12742978Mancini D, Pinney S, Burkhoff D, LaManca J, Itescu S, Burke E, Edwards N, Oz M, Marks AR. Use of rapamycin slows progression of cardiac transplantation vasculopathy. Circulation. 2003 Jul 8;108(1):48-53. doi: 10.1161/01.CIR.0000070421.38604.2B. Epub 2003 May 12.
- Background: PubMed 15262845Keogh A, Richardson M, Ruygrok P, Spratt P, Galbraith A, O'Driscoll G, Macdonald P, Esmore D, Muller D, Faddy S. Sirolimus in de novo heart transplant recipients reduces acute rejection and prevents coronary artery disease at 2 years: a randomized clinical trial. Circulation. 2004 Oct 26;110(17):2694-700. doi: 10.1161/01.CIR.0000136812.90177.94. Epub 2004 Jul 19.
- Background: PubMed 18025531Raichlin E, Bae JH, Khalpey Z, Edwards BS, Kremers WK, Clavell AL, Rodeheffer RJ, Frantz RP, Rihal C, Lerman A, Kushwaha SS. Conversion to sirolimus as primary immunosuppression attenuates the progression of allograft vasculopathy after cardiac transplantation. Circulation. 2007 Dec 4;116(23):2726-33. doi: 10.1161/CIRCULATIONAHA.107.692996. Epub 2007 Nov 19.
Related trials for Cardiac Allograft Vasculopathy
RecruitingPhase 3
AERIAL Trial: Antiplatelet Therapy in Heart Transplantation
Cardiac Allograft Vasculopathy, Heart Transplant
Recruiting
MARINER Trial: Multiparametric Cardiac PET for CAV Surveillance After Heart Transplantation
Cardiac Allograft Vasculopathy
Active, not recruitingObservational study
Early Post Transplant Cardiac Allograft Vasculopathy
Cardiac Allograft Vasculopathy
Not yet recruitingObservational study
Comparing PCCT With ICA and IVUS in Detecting Cardiac Allograft Vasculopathy
Cardiac Allograft Vasculopathy
RecruitingObservational study
Physiologic Assessment of Microvascular Function in Heart Transplant Patients
Cardiac Allograft Vasculopathy
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?
A study testing Sirolimus in people with 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 7 inclusion and 16 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 24 Jan 2017. 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?
1. Change in maximal intimal thickness (time frame: 1, 2, 3 and 4 years). 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 NCT01305395, which also lists 13 linked publications.
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 24 Jan 2017; AzTrials last refreshed its copy on 8 Nov 2026.