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| Name | Class |
|---|---|
| Astellas Pharma Inc | INDUSTRY |
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The investigators will use cardiac MRI to measure the myocardial perfusion reserve and amount of myocardial edema and fibrosis in heart-transplant patients with nonspecific allograft dysfunction in contrast to those with normal graft function. The investigators hypothesize that patients with nonspecific allograft dysfunction will demonstrate decreased myocardial perfusion reserve, related to microvascular allograft vasculopathy, compared to those with normal graft function.
Adult heart-transplant patients, excluding those with a GFR less than 30 mL/min/1.73m2, contraindications to MRI and allergies to either regadenoson or gadolinium contrast, will be enrolled over 10 months. Patients will be recruited from UC San Diego and San Diego Veterans Affairs. The investigators will specifically enroll patients with nonspecific allograft dysfunction and patients with normal graft function.
Brief protocol:
Cardiac MRI is performed. Cine images in standard views are obtained. T2 mapping sequences are performed on short axis images. For stress imaging, intravenous regadenoson is given as a 0.4 mg bolus followed by a 5 mL saline flush. After 30 seconds, short-axis images are acquired for 30 consecutive heartbeats with administration of gadolinium. Rest imaging is performed 30 minutes after stress imaging. Lastly, late gadolinium enhancement images are obtained in standard views. Images are analyzed offline by a blinded independent reader. Patients will be followed for one month after enrollment for MACE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nonspecific allograft dysfunction | Experimental | Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart. |
|
| Normal graft function | Experimental | Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regadenoson | Drug | For use in stress myocardial perfusion imaging. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial Perfusion Reserve | Myocardial perfusion reserve calculates the increase in myocardial perfusion after stress in comparison to rest. Outcome measure time frame specifies when the myocardial perfusion reserve was obtained in relation to date of heart-transplant for each patient. This was a one time measurement made after heart-transplantation. | Range of 1 to 12 years after heart transplantation for subjects and an average of 4 years after heart-transplantation. |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial Ischemia/Infarction | Myocardial ischemia or infarct occurring from time of enrollment (when cardiac MRI performed) over subsequent 10 month period. | 10 months after enrollment (when cardiac MRI was performed) |
| Hospitalization for Cardiac Related Causes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul J Kim, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego | La Jolla | California | 92037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21962016 | Background | Stehlik J, Edwards LB, Kucheryavaya AY, Benden C, Christie JD, Dobbels F, Kirk R, Rahmel AO, Hertz MI. The Registry of the International Society for Heart and Lung Transplantation: Twenty-eighth Adult Heart Transplant Report--2011. J Heart Lung Transplant. 2011 Oct;30(10):1078-94. doi: 10.1016/j.healun.2011.08.003. No abstract available. | |
| 21555100 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nonspecific Allograft Dysfunction | Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart. Regadenoson: For use in stress myocardial perfusion imaging. Gadolinium: For use in both perfusion imaging and late gadolinium enhancement. Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart. |
| FG001 | Normal Graft Function | Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart. Regadenoson: For use in stress myocardial perfusion imaging. Gadolinium: For use in both perfusion imaging and late gadolinium enhancement. Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nonspecific Allograft Dysfunction | Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart. Regadenoson: For use in stress myocardial perfusion imaging. Gadolinium: For use in both perfusion imaging and late gadolinium enhancement. Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Myocardial Perfusion Reserve | Myocardial perfusion reserve calculates the increase in myocardial perfusion after stress in comparison to rest. Outcome measure time frame specifies when the myocardial perfusion reserve was obtained in relation to date of heart-transplant for each patient. This was a one time measurement made after heart-transplantation. | Posted | Mean | Standard Deviation | arbitrary units | Range of 1 to 12 years after heart transplantation for subjects and an average of 4 years after heart-transplantation. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nonspecific Allograft Dysfunction | Patients with nonspecific allograft dysfunction will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart. Regadenoson: For use in stress myocardial perfusion imaging. Gadolinium: For use in both perfusion imaging and late gadolinium enhancement. Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Kim, MD | UCSD | 3104907217 | pjk017@ucsd.edu |
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| ID | Term |
|---|---|
| C430916 | regadenoson |
| D005682 | Gadolinium |
| D019786 | Gadolinium DTPA |
| ID | Term |
|---|---|
| D028581 | Lanthanoid Series Elements |
| D008674 | Metals, Rare Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
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| Gadolinium | Drug | For use in both perfusion imaging and late gadolinium enhancement. |
|
|
| Cardiac MRI | Procedure | Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart. |
|
Hospitalization for cardiac related causes after enrollment. Time frame after enrollment (date of cardiac MRI) was 10 months |
| 10 months after enrollment (from date of cardiac MRI) |
| Re-transplantation | Re-transplantation of the heart after enrollment (date of cardiac MRI). Measured 10 months after enrollment. | 10 months after enrollment (from date of cardiac MRI) |
| Late Gadolinium Enhancement | Late gadolinium enhancement demonstrates myocardial scar by cardiac MRI. This is measured the day of the cardiac MRI scan and is a one time measurement. Time frame is measurement of late gadolinium enhancement from date of heart-transplantation. | Range of 1 to 12 years after heart transplantation for subjects and an average of 4 years after heart-transplantation. |
| Mean Segmental T1 Values of the Left Ventricle | T1 values are obtained at the time of the cardiac MRI and indicate the amount of myocardial edema. This was a one time measurement. Outcome measure time frame indicates when T1 values of the left ventricle were obtained in relation to heart-transplantation. | Range of 1 to 12 years after heart transplantation for subjects and an average of 4 years after heart-transplantation. |
| Berry GJ, Angelini A, Burke MM, Bruneval P, Fishbein MC, Hammond E, Miller D, Neil D, Revelo MP, Rodriguez ER, Stewart S, Tan CD, Winters GL, Kobashigawa J, Mehra MR. The ISHLT working formulation for pathologic diagnosis of antibody-mediated rejection in heart transplantation: evolution and current status (2005-2011). J Heart Lung Transplant. 2011 Jun;30(6):601-11. doi: 10.1016/j.healun.2011.02.015. No abstract available. |
| 20643330 | Background | Costanzo MR, Dipchand A, Starling R, Anderson A, Chan M, Desai S, Fedson S, Fisher P, Gonzales-Stawinski G, Martinelli L, McGiffin D, Smith J, Taylor D, Meiser B, Webber S, Baran D, Carboni M, Dengler T, Feldman D, Frigerio M, Kfoury A, Kim D, Kobashigawa J, Shullo M, Stehlik J, Teuteberg J, Uber P, Zuckermann A, Hunt S, Burch M, Bhat G, Canter C, Chinnock R, Crespo-Leiro M, Delgado R, Dobbels F, Grady K, Kao W, Lamour J, Parry G, Patel J, Pini D, Towbin J, Wolfel G, Delgado D, Eisen H, Goldberg L, Hosenpud J, Johnson M, Keogh A, Lewis C, O'Connell J, Rogers J, Ross H, Russell S, Vanhaecke J; International Society of Heart and Lung Transplantation Guidelines. The International Society of Heart and Lung Transplantation Guidelines for the care of heart transplant recipients. J Heart Lung Transplant. 2010 Aug;29(8):914-56. doi: 10.1016/j.healun.2010.05.034. No abstract available. |
| 3308166 | Background | Uretsky BF, Murali S, Reddy PS, Rabin B, Lee A, Griffith BP, Hardesty RL, Trento A, Bahnson HT. Development of coronary artery disease in cardiac transplant patients receiving immunosuppressive therapy with cyclosporine and prednisone. Circulation. 1987 Oct;76(4):827-34. doi: 10.1161/01.cir.76.4.827. |
| 11943259 | Background | Fang JC, Kinlay S, Beltrame J, Hikiti H, Wainstein M, Behrendt D, Suh J, Frei B, Mudge GH, Selwyn AP, Ganz P. Effect of vitamins C and E on progression of transplant-associated arteriosclerosis: a randomised trial. Lancet. 2002 Mar 30;359(9312):1108-13. doi: 10.1016/S0140-6736(02)08154-0. |
| 20413602 | Background | Pham MX, Teuteberg JJ, Kfoury AG, Starling RC, Deng MC, Cappola TP, Kao A, Anderson AS, Cotts WG, Ewald GA, Baran DA, Bogaev RC, Elashoff B, Baron H, Yee J, Valantine HA; IMAGE Study Group. Gene-expression profiling for rejection surveillance after cardiac transplantation. N Engl J Med. 2010 May 20;362(20):1890-900. doi: 10.1056/NEJMoa0912965. Epub 2010 Apr 22. |
| 16890123 | Background | Bhalodolia R, Cortese C, Graham M, Hauptman PJ. Fulminant acute cellular rejection with negative findings on endomyocardial biopsy. J Heart Lung Transplant. 2006 Aug;25(8):989-92. doi: 10.1016/j.healun.2006.04.002. Epub 2006 Jun 30. |
| 24355800 | Background | Miller CA, Sarma J, Naish JH, Yonan N, Williams SG, Shaw SM, Clark D, Pearce K, Stout M, Potluri R, Borg A, Coutts G, Chowdhary S, McCann GP, Parker GJ, Ray SG, Schmitt M. Multiparametric cardiovascular magnetic resonance assessment of cardiac allograft vasculopathy. J Am Coll Cardiol. 2014 Mar 4;63(8):799-808. doi: 10.1016/j.jacc.2013.07.119. Epub 2013 Dec 18. |
| 11693758 | Background | Marie PY, Angioi M, Carteaux JP, Escanye JM, Mattei S, Tzvetanov K, Claudon O, Hassan N, Danchin N, Karcher G, Bertrand A, Walker PM, Villemot JP. Detection and prediction of acute heart transplant rejection with the myocardial T2 determination provided by a black-blood magnetic resonance imaging sequence. J Am Coll Cardiol. 2001 Mar 1;37(3):825-31. doi: 10.1016/s0735-1097(00)01196-7. |
| 19284612 | Background | Butler CR, Thompson R, Haykowsky M, Toma M, Paterson I. Cardiovascular magnetic resonance in the diagnosis of acute heart transplant rejection: a review. J Cardiovasc Magn Reson. 2009 Mar 12;11(1):7. doi: 10.1186/1532-429X-11-7. |
| 18551063 | Background | Kubrich M, Petrakopoulou P, Kofler S, Nickel T, Kaczmarek I, Meiser BM, Reichart B, von Scheidt W, Weis M. Impact of coronary endothelial dysfunction on adverse long-term outcome after heart transplantation. Transplantation. 2008 Jun 15;85(11):1580-7. doi: 10.1097/TP.0b013e318170b4cd. |
| 24457279 | Background | Solberg OG, Ragnarsson A, Kvarsnes A, Endresen K, Kongsgard E, Aakhus S, Gullestad L, Stavem K, Aaberge L. Reference interval for the index of coronary microvascular resistance. EuroIntervention. 2014 Jan 22;9(9):1069-75. doi: 10.4244/EIJV9I9A181. |
| BG001 | Normal Graft Function | Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart. Regadenoson: For use in stress myocardial perfusion imaging. Gadolinium: For use in both perfusion imaging and late gadolinium enhancement. Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Normal Graft Function | Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart. Regadenoson: For use in stress myocardial perfusion imaging. Gadolinium: For use in both perfusion imaging and late gadolinium enhancement. Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart. |
|
|
| Secondary | Myocardial Ischemia/Infarction | Myocardial ischemia or infarct occurring from time of enrollment (when cardiac MRI performed) over subsequent 10 month period. | Posted | Count of Participants | Participants | 10 months after enrollment (when cardiac MRI was performed) |
|
|
|
| Secondary | Hospitalization for Cardiac Related Causes | Hospitalization for cardiac related causes after enrollment. Time frame after enrollment (date of cardiac MRI) was 10 months | Posted | Count of Participants | Participants | 10 months after enrollment (from date of cardiac MRI) |
|
|
|
| Secondary | Re-transplantation | Re-transplantation of the heart after enrollment (date of cardiac MRI). Measured 10 months after enrollment. | Posted | Count of Participants | Participants | 10 months after enrollment (from date of cardiac MRI) |
|
|
|
| Secondary | Late Gadolinium Enhancement | Late gadolinium enhancement demonstrates myocardial scar by cardiac MRI. This is measured the day of the cardiac MRI scan and is a one time measurement. Time frame is measurement of late gadolinium enhancement from date of heart-transplantation. | Posted | Mean | Standard Deviation | percentage of myocardium | Range of 1 to 12 years after heart transplantation for subjects and an average of 4 years after heart-transplantation. |
|
|
|
| Secondary | Mean Segmental T1 Values of the Left Ventricle | T1 values are obtained at the time of the cardiac MRI and indicate the amount of myocardial edema. This was a one time measurement. Outcome measure time frame indicates when T1 values of the left ventricle were obtained in relation to heart-transplantation. | Posted | Mean | Standard Deviation | Percentage of myocardium | Range of 1 to 12 years after heart transplantation for subjects and an average of 4 years after heart-transplantation. |
|
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|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Normal Graft Function | Patients with normal graft function will undergo stress cardiac MRI with regadenoson in addition to performing late gadolinium enhancement and obtaining mean segmental T1 values of the heart. Regadenoson: For use in stress myocardial perfusion imaging. Gadolinium: For use in both perfusion imaging and late gadolinium enhancement. Cardiac MRI: Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart. | 0 | 8 | 0 | 8 | 0 | 8 |
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| D008670 |
| Metals |
| D004369 | Pentetic Acid |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D056831 | Coordination Complexes |