Registr výsledků Surveillance HeartCare®

Registr výsledků Surveillance HeartCare®

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Hlavní sponzor: CareDx

Zdroj CareDx
Stručné shrnutí

Toto je observační registr k posouzení klinické účinnosti pomocí dozoru Testovací služby HeartCare ve spojení s klinickou péčí o transplantaci srdce.

Detailní popis

HeartCare je služba, která zahrnuje AlloMap® a AlloSure-Heart® k poskytování informací pomozte klinickým lékařům komplexněji monitorovat aloštěp u příjemců transplantací srdce odmítnout. Přístup ke sledování pomocí HeartCare poskytuje informace ze dvou doplňková opatření; AlloMap je míra imunitní reakce hostitele založeného na profilu genové exprese aktivita a riziko akutního odmítnutí. AlloSure-Heart sleduje poranění štěpu. AlloMap je první test schválený FDA a je určen neinvazivní metodou krevních testů doporučenou v Pokyny pro dohled a Mezinárodní společnost pro transplantace srdce a plic (ISHLT) příjemců transplantace srdce k odmítnutí. AlloSure-Heart měří bezbuněčné dárcovské buňky DNA (dd-cfDNA), která pomáhá rozlišovat akutní odmítnutí buněk a odmítnutí zprostředkované protilátkami bez odmítnutí. Pacienti, kteří dostávají HeartCare jako součást své transplantace vedení, dá informovaný souhlas s informacemi o jejich výsledcích a další spolupráci klinické informace nalezené v lékařských záznamech, které mají být vloženy do databáze SHORE pro účely studie.

Celkový stav Nábor
Počáteční datum 2018-12-28
Datum dokončení 2027-06-01
Datum primárního dokončení 2024-12-01
Typ studie Pozorovací
Primární výsledek
Opatření Časové okno
Procento pacientů naživu jeden, dva a tři roky po transplantaci. Prosinec-2024
Zápis 3450
Stav
Zásah

Typ intervence: jiný

Název intervence: Standartní péče

Popis: Další standardní opatření pro monitorování odmítnutí: Endomyokardiální biopsie, echokardiogram, angiografie, intravaskulární ultrazvuk, HLA protilátka specifická pro dárce

Způsobilost

Metoda vzorkování:

Pravděpodobnostní vzorek

Kritéria:

Kritéria pro zařazení: 1. Pacienti, kteří jsou v době odběru krve starší 15 let. 2. Dostali jste transplantaci srdce (primární nebo opakovanou) 3. Pacienti, u kterých byla léčba HeartCare zahájena do 3 měsíců po transplantaci Kritéria pro vyloučení: 1. Pacientky, které jsou těhotné v době odběru krve.

Rod:

Všechno

Minimální věk:

15 let

Maximální věk:

N / A

Zdraví dobrovolníci:

Ne

Celkově oficiální
Příjmení Role Přidružení
James P Yee, MD, PhD Study Director CareDx
Celkový kontakt

Příjmení: Sham Dholakia

Telefon: 415-287-2374

E-mailem: [email protected]

Umístění
Zařízení: Postavení: Kontakt: Vyšetřovatel:
Mayo Clinic Arizona | Phoenix, Arizona, 85054, United States Recruiting Saran G. Vaughn 480-342-6487 [email protected] Eric Steidley, MD Principal Investigator
UC San Diego | La Jolla, California, 92037, United States Completed
Cedars-Sinai Medical Center | Los Angeles, California, 90048, United States Recruiting Irina Cozianu 310-248-7134 [email protected] Jon Kobashigawa, MD Principal Investigator
University of California, Los Angeles | Los Angeles, California, 90095, United States Recruiting Ladda Douangvila 310-794-4797 [email protected] Mario Deng, MD Sub-Investigator Daniel Cruz, MD Sub-Investigator Ali Nsair, MD Sub-Investigator Arnold Baas, MD Sub-Investigator Megan Kamath, MD Principal Investigator
University of Southern California | Los Angeles, California, 94003, United States Recruiting Melissa Ramos 323-442-7983 [email protected] Eugene Depasquale, MD Principal Investigator Joseph Rahman, MD Sub-Investigator Mark Barr, MD Sub-Investigator
California Pacific Medical Center | San Francisco, California, 94115, United States Recruiting Hannah Potter [email protected] Ranjan Ray, MD Sub-Investigator Jared Herr, MD Sub-Investigator Yu Xie, MD Sub-Investigator Michael Pham, MD Principal Investigator
UCSF Medical Center | San Francisco, California, 94143, United States Recruiting Natalia Dikinov [email protected] Teresa DeMarco, MD Principal Investigator
Stanford University | Stanford, California, 94305, United States Recruiting Julie Gordon [email protected] Kiran Khush, MD Principal Investigator Jeffrey Teuteberg, MD Sub-Investigator
Yale New Haven | New Haven, Connecticut, 06519, United States Recruiting Lynn Wilson [email protected] Lavanya Bellumkonda, MD Principal Investigator
Medstar Washington Hospital Center | Washington, District of Columbia, 20010, United States Recruiting Hellina Birru [email protected] Maria Rodrigo, MD Principal Investigator Samer Najjar, MD Sub-Investigator Selma Mohammed, MD Sub-Investigator
Memorial Healthcare System | Hollywood, Florida, 33021, United States Recruiting Jill Granado [email protected] Priyanka Gosain, MD Principal Investigator Maria Avila Robles, MD Sub-Investigator Ioana Dumitru, MD Sub-Investigator
Mayo Clinic- Florida | Jacksonville, Florida, 32224, United States Recruiting Katelyn H. Register, MS, CCRP 904-953-8503 [email protected] Juan Carlos Leoni Moreno, MD Principal Investigator
University of Miami | Miami, Florida, 33136, United States Recruiting Eugene Bauerlein [email protected] Sandra Chaparro, MD Principal Investigator
AdventHealth | Orlando, Florida, 32804, United States Recruiting Deanna Allen [email protected] Nirav Raval, MD Principal Investigator
Tampa General Hospital | Tampa, Florida, 33606, United States Recruiting Laurie Joughin, RN 813-844-8153 [email protected] Peter Berman, MD Principal Investigator Debbie Rinde-Hoffman, MD Sub-Investigator Benjamin Mackie, MD Sub-Investigator Mark Weston, MD Sub-Investigator Siva Kumar, MD Sub-Investigator Jason Feliberti, MD Sub-Investigator Luis Arroyo, MD Sub-Investigator
Piedmont Heart Institute | Atlanta, Georgia, 30309, United States Recruiting Andrew Bailey, RN 404-605-4098 [email protected] Arun Krishnamoorthy, MD Principal Investigator
Northwestern University | Chicago, Illinois, 60611, United States Recruiting Jack Geocaris [email protected] Kambiz Ghafourian, MD Principal Investigator
University of Chicago Medicine | Chicago, Illinois, 60637, United States Recruiting Amy Bennett [email protected] Nir Uriel, MD Principal Investigator Gabriel Sayer, MD Sub-Investigator Gene Kim, MD Sub-Investigator
Loyola University Medical Center | Maywood, Illinois, 60153, United States Recruiting Carol Kartje [email protected] Max Liebo, MD Principal Investigator
Advocate Christ Medical Center | Oak Lawn, Illinois, 60453, United States Not yet recruiting Chris Doherty [email protected] William Cotts, MD Principal Investigator
Indiana University School of Medicine | Indianapolis, Indiana, 46202, United States Recruiting Charlene Jones [email protected] Roopa Rao, MD Principal Investigator
St. Vincent Hospital and Health Care Center, Inc. | Indianapolis, Indiana, 46260, United States Recruiting Melanie Glover 317-338-8042 [email protected] Ashwin Ravichandran, MD Principal Investigator Mary Walsh, MD Sub-Investigator Sunit-Preet Chaudhry, MD Sub-Investigator Amit Patel, MD Sub-Investigator Rafael Garcia-Cortes, MD Sub-Investigator Thomas Schleeter, MD Sub-Investigator
The University of Kansas Medical Center | Kansas City, Kansas, 66160, United States Recruiting Tyler Zimmer 913-588-5718 [email protected] Nicholas Haglund, MD Principal Investigator
Ochsner Clinic Foundation | New Orleans, Louisiana, 70121, United States Recruiting Nilmo Hernandez 504-703-3265 [email protected] Selim Krim, MD Principal Investigator
Tufts Medical Center | Boston, Massachusetts, 02111, United States Recruiting Laura Telfer [email protected] Amanda Vest, MD Principal Investigator
Massachusetts General Hospital | Boston, Massachusetts, 02114, United States Recruiting Diane Cocca-Spofford [email protected] Gregory Lewis, MD Principal Investigator
Henry Ford Hospitals | Detroit, Michigan, 48202, United States Recruiting Cristina Tita [email protected] Cristina Tita, MD Principal Investigator Jennifer Cowger, MD Sub-Investigator David Lanfrear, MD Sub-Investigator Gillian Grafton, MD Sub-Investigator Yelena Selektor, MD Sub-Investigator Celeste Williams, MD Sub-Investigator
Henry Ford Hospital | Detroit, Michigan, 48202, United States Recruiting Shereen Mukhashen [email protected] Cristina Tita, MD Principal Investigator
Spectrum Health | Grand Rapids, Michigan, 49503, United States Recruiting Morgan Maley 616-391-0921 [email protected] Ryan Grayburn, MD Principal Investigator
St. Luke's Hospital of Kansas City | Kansas City, Missouri, 64111, United States Recruiting Karen Haffey [email protected] Andrew Kao, MD Principal Investigator
Barnes Jewish Hospital, Washington University | Saint Louis, Missouri, 63110, United States Recruiting Annie Dirks [email protected] Gregory Ewald, MD Principal Investigator
University of Nebraska Medical Center | Omaha, Nebraska, 68198, United States Completed
Montefiore Medical Center | Bronx, New York, 10467, United States Recruiting Nadia Rampersaud [email protected] Snehal R. Patel, MD Principal Investigator
Northwell Health/ North Shore University Hospital | Manhasset, New York, 11030, United States Recruiting Keriann Leppla [email protected] Gerin Stevens, MD Principal Investigator
NYU Grossman School of Medicine | New York, New York, 10016, United States Recruiting Rebecca Dieter [email protected] Claudia Gidea, MD Principal Investigator
NYU Langone Health | New York, New York, 10016, United States Recruiting Rebecca Dieter [email protected] Claudia Gidea, MD Principal Investigator
Icahn School of Medicine at Mount Sinai | New York, New York, 10029, United States Recruiting Pilar Tlachi [email protected] Maya Barghash, MD Principal Investigator
Columbia University Irving Medical Center | New York, New York, 10032, United States Recruiting Andrea Kim 212-305-1429 [email protected] Farhana Latif, MD Principal Investigator
The Trustees of Columbia University | New York, New York, 10032, United States Recruiting Andrea Kim 212-305-1429 [email protected] Farhana Latif, MD Principal Investigator
University of Rochester Medical Center | Rochester, New York, 14642, United States Recruiting Laura Wing [email protected] Leway Chen, MD Principal Investigator
Mayo Clinic Rochester | Rochester, New York, 55905, United States Recruiting Avudaiappan Chokkalingam 507-422-6061 [email protected] Alfredo Clavell, MD Principal Investigator
University of North Carolina at Chapel Hill | Chapel Hill, North Carolina, 27599, United States Recruiting Tyrone Wade 919-962-4896 [email protected] Patricia P Chang, MD Principal Investigator Brian Jensen, MD Sub-Investigator Lisa Rose-Jones, MD Sub-Investigator Mirnela Byku, MD Sub-Investigator Megan Andrews, MD Sub-Investigator
Wake Forest Medical Center | Winston-Salem, North Carolina, 27157, United States Recruiting Karen Blinson [email protected] TJ O'neill, MD Principal Investigator
Cleveland Clinic | Cleveland, Ohio, 44195, United States Recruiting Barbara Gus [email protected] Eileen Hsich, MD Principal Investigator
The Ohio State University | Columbus, Ohio, 43210, United States Recruiting Andrew Huffman [email protected] Brent Lampert, MD Principal Investigator
Integris Baptist Medical Center | Oklahoma City, Oklahoma, 73112, United States Recruiting Kristin Mund [email protected] Luke Cunningham, MD Principal Investigator
Oregon Health and Science University | Portland, Oregon, 97239, United States Recruiting John Halvorson 503-418-1679 [email protected] Johannes Steiner, MD Principal Investigator Luke Masha, MD Sub-Investigator Nalini Colaco, MD Sub-Investigator Kellie Graham, MD Sub-Investigator
Penn State Health Milton S. Hershey Medical Center | Hershey, Pennsylvania, 17033, United States Recruiting Kevin Gardner [email protected] Howard Eisen, MD Principal Investigator
University of Pennsylvania | Philadelphia, Pennsylvania, 19104, United States Recruiting Kimberly Clinton [email protected] Rhondalyn C Forde-Mclean, MD Principal Investigator
Allegheny-Singer Research Institute | Pittsburgh, Pennsylvania, 15212, United States Recruiting Laurie Machen [email protected] Manreet Kanwar, MD Principal Investigator
University of Pittsburgh Medical Center | Pittsburgh, Pennsylvania, 15213, United States Recruiting Traci Mc Gaha 415-287-2643 [email protected] Mary Keebler, MD Principal Investigator
Medical University of South Carolina | Charleston, South Carolina, 29425, United States Recruiting Anthony Awkar, MD [email protected] Adrian B Van Bakel, MD Principal Investigator
Stern Cardiovascular Foundation | Germantown, Tennessee, 38138, United States Recruiting Brian Dragutsky 901-504-0208 Todd Edwards, MD Principal Investigator Jaime Watkins, FNP Sub-Investigator Amanda Allen, FNP Sub-Investigator
Saint Thomas Health | Nashville, Tennessee, 37205, United States Completed
Seton Heart Institute | Austin, Texas, 78705, United States Recruiting Sarah Benedict 512-324-9999 18171 [email protected] Mary Beth Cishek, MD Principal Investigator
Medical City Dallas | Dallas, Texas, 75230, United States Recruiting Aline Barzilla [email protected] Jacob Chemmalakuzhy, MD Principal Investigator
Baylor Research Institute | Dallas, Texas, 75246, United States Recruiting Shane Blankenship 214-818-7639 [email protected] Shelley Hall, MD Principal Investigator
UT Southwestern Medical Center | Dallas, Texas, 75390, United States Recruiting Carolyn Kelly 214-645-8040 [email protected] Pradeep Mammen, MD Principal Investigator
Baylor St. Luke's Medical Center | Houston, Texas, 77030, United States Recruiting Murali Gali, MBBS, MHA 713-798-1037 [email protected] Ajith Nair, MD Principal Investigator
Houston Methodist Research Institute | Houston, Texas, 77030, United States Completed
UTHealth/ Memorial Hermann Hospital | Houston, Texas, 77030, United States Recruiting Brandon Morrow [email protected] Sriram Nathan, MD Principal Investigator
Methodist Healthcare Systems of San Antonio | San Antonio, Texas, 78229, United States Recruiting Gloria Carrreon 210-825-9369 [email protected] Phillip Habib, MD Principal Investigator
Intermountain Heart Institute | Murray, Utah, 84107, United States Recruiting Heather Maestas 801-507-4951 [email protected] Rami Alharethi, MD Principal Investigator
Inova Fairfax Medical Campus | Falls Church, Virginia, 22042, United States Recruiting Stephanie Garfalo [email protected] Palak Shah, MD Principal Investigator
Sentara Cardiovascular Research Institute | Norfolk, Virginia, 23507, United States Completed
University of Washington | Seattle, Washington, 98115, United States Recruiting Sarah Atkinson [email protected] Richard Cheng, MD Principal Investigator Elina Minami, MD Sub-Investigator
University of Wisconsin School of Medicine and Public Health | Madison, Wisconsin, 53726, United States Recruiting Karen Olson, RN 608-263-1544 [email protected] Ravi Dhingra, MD Principal Investigator
Aurora Health Care | Milwaukee, Wisconsin, 53215, United States Recruiting Reva Matz, RN [email protected] Nasir Sulemanjee, MD Principal Investigator
Medical College of Wisconsin | Milwaukee, Wisconsin, 53226, United States Recruiting Ashley Schwarz, RN [email protected] Nunzio Gaglianello, MD Sub-Investigator Renee Kursel, MD Sub-Investigator Asim Mohammed, MD Sub-Investigator Mitchell Saltzberg, MD Sub-Investigator David C Ishizawar, MD Principal Investigator
Země umístění

United States

Datum ověření

2021-06-01

Odpovědná strana

Typ: Sponzor

Rozšířil přístup Ne
Skupina paží

Označení: HeartCare

Popis: Diagnostic Test: Heart Care 2300 patients managed with HeartCare (AlloMap® and AlloSure-Heart® )

Označení: Řízení

Popis: Historická kontrolní skupina bude přiřazena k odhadovaným 1150 pacientům ve skupině HeartCare, kteří absolvují alespoň dva roky sledování pomocí HeartCare, včetně klinického sledování po transplantaci výsledku pro rok 3. Kritéria pro odpovídající kontroly budou založena na typu dárce aloštěpu, věku, pohlaví, etnickém původu / rase a dalších klinických faktorech. K provedení shody se použije skóre sklonu.

Akronym SHORE
Informace o studijním designu

Pozorovací model: Kohorta

Časová perspektiva: Budoucí

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