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| Name | Class |
|---|---|
| New England Congenital Cardiology Association (NECCA) | UNKNOWN |
| Yale University | OTHER |
| Dartmouth College | OTHER |
| Connecticut Children's Medical Center |
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This study aims to determine what are some of the clinical characteristics and associations of Fontan patients who are doing well, as well as how accurate cardiology providers are at predicting the likelihood of future adverse event in their Fontan patients.
This is a multi-center prospective study that involves collecting data from patients as well as their cardiology providers in order to determine whether there is correlation between patient-reported quality of life assessments and clinician-identified assessments of their patients. The study also involves collecting data from the medical records of participating patients and entering it into our study database.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric Fontan Patients | Participants ages 10 to 18 who have had Lateral Tunnel or Extracardiac Fontan procedures. | ||
| Adult Fontan Patients | Participants ages 18 to 60 who have had Lateral Tunnel or Extracardiac Fontan procedures. |
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| Measure | Description | Time Frame |
|---|---|---|
| Surprise question | The ability of the cardiologist's response to the "surprise" question to predict adverse cardiac events within 1 year | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical characteristics and associations of the "good Fontan" | Clinical characteristics and associations of this group (the "good Fontan") are different compared to those that are in the "at-risk" category (all others that do not fit into the "good Fontan" category). Data measurements will include relevant clinical data available for each patient, including but not limited to data from cardiac surgeries, catheterizations, MRIs, echocardiograms, exercise stress tests, current medications, labs, and patient responses to questionnaires. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with congenital heart disease who have undergone the Fontan procedure.
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| Name | Affiliation | Role |
|---|---|---|
| Rahul Rathod, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17846297 | Background | d'Udekem Y, Iyengar AJ, Cochrane AD, Grigg LE, Ramsay JM, Wheaton GR, Penny DJ, Brizard CP. The Fontan procedure: contemporary techniques have improved long-term outcomes. Circulation. 2007 Sep 11;116(11 Suppl):I157-64. doi: 10.1161/CIRCULATIONAHA.106.676445. | |
| 20929979 | Background | Diller GP, Giardini A, Dimopoulos K, Gargiulo G, Muller J, Derrick G, Giannakoulas G, Khambadkone S, Lammers AE, Picchio FM, Gatzoulis MA, Hager A. Predictors of morbidity and mortality in contemporary Fontan patients: results from a multicenter study including cardiopulmonary exercise testing in 321 patients. Eur Heart J. 2010 Dec;31(24):3073-83. doi: 10.1093/eurheartj/ehq356. Epub 2010 Oct 7. |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D000080039 | Univentricular Heart |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| OTHER |
| University of Vermont | OTHER |
| Child Heart Associates | UNKNOWN |
| Congenital Heart | UNKNOWN |
| University of Massachusetts, Worcester | OTHER |
| Massachusetts General Hospital | OTHER |
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| 1 year |
| Correlation between patient and provider assessments | There will be a positive correlation of the patient's own assessment of quality of life with the clinician-identified designation of a "good Fontan." | 1 year |
| Clinician factors associated with adverse events conversation with patients | Clinician factors (years of experience, primary subspecialty, gender, parenthood) are associated with beliefs in regard to appropriate timing to discuss potential long-term adverse events to Fontan patients. | 1 year |
| 24583501 | Background | Blume ED, Balkin EM, Aiyagari R, Ziniel S, Beke DM, Thiagarajan R, Taylor L, Kulik T, Pituch K, Wolfe J. Parental perspectives on suffering and quality of life at end-of-life in children with advanced heart disease: an exploratory study*. Pediatr Crit Care Med. 2014 May;15(4):336-42. doi: 10.1097/PCC.0000000000000072. |
| 27695853 | Background | Lakin JR, Robinson MG, Bernacki RE, Powers BW, Block SD, Cunningham R, Obermeyer Z. Estimating 1-Year Mortality for High-Risk Primary Care Patients Using the "Surprise" Question. JAMA Intern Med. 2016 Dec 1;176(12):1863-1865. doi: 10.1001/jamainternmed.2016.5928. No abstract available. |
| 26054631 | Background | Hamano J, Morita T, Inoue S, Ikenaga M, Matsumoto Y, Sekine R, Yamaguchi T, Hirohashi T, Tajima T, Tatara R, Watanabe H, Otani H, Takigawa C, Matsuda Y, Nagaoka H, Mori M, Yamamoto N, Shimizu M, Sasara T, Kinoshita H. Surprise Questions for Survival Prediction in Patients With Advanced Cancer: A Multicenter Prospective Cohort Study. Oncologist. 2015 Jul;20(7):839-44. doi: 10.1634/theoncologist.2015-0015. Epub 2015 Jun 8. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |