The United States Chronic Thromboembolic Pulmonary Hypertension Registry: Protocol for a Prospective, Longitudinal Study.
CTEPH
nonsurgical
pulmonary embolism
pulmonary hypertension
registry
surgical
therapy
treatment
Journal
JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504
Informations de publication
Date de publication:
25 May 2021
25 May 2021
Historique:
received:
02
11
2020
accepted:
13
04
2021
revised:
24
03
2021
pubmed:
14
4
2021
medline:
14
4
2021
entrez:
13
4
2021
Statut:
epublish
Résumé
Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare sequela of acute pulmonary embolism that is treatable when recognized. Awareness of this disease has increased with recent advancements in therapeutic options, but delays in diagnosis remain common, and diagnostic and treatment guidelines are often not followed. Data gathered from international registries have improved our understanding of CTEPH, but these data may not be applicable to the US population owing to differences in demographics and medical practice patterns. The US CTEPH Registry (US-CTEPH-R) was developed to provide essential information to better understand the demographics, risk factors, evaluation, and treatment of CTEPH in the United States, as well as the short- and long-term outcomes of surgical and nonsurgical therapies in the modern treatment era. Thirty sites throughout the United States enrolled 750 subjects in this prospective, longitudinal, observational registry of patients newly diagnosed with CTEPH. Enrollment criteria included a mean pulmonary artery pressure ≥25 mmHg by right heart catheterization and radiologic confirmation of CTEPH by a multidisciplinary adjudication committee. Following enrollment, subjects were followed biannually until the conclusion of the study. Quality of life surveys were administered at enrollment and biannually, and all other testing was at the discretion of the treating clinician. Details regarding surgical therapy, balloon pulmonary angioplasty, and medical therapy were collected at enrollment and at follow-up, as well as information related to health care utilization and survival. Data from this registry will improve understanding of the demographics, risk factors, and treatment patterns of patients with CTEPH, and the longitudinal impact of therapies on quality of life, health care utilization, and survival. This manuscript details the methodology and design of the first large, prospective, longitudinal registry of patients with CTEPH in the United States. ClinicalTrials.gov NCT02429284; https://www.clinicaltrials.gov/ct2/show/NCT02429284. DERR1-10.2196/25397.
Sections du résumé
BACKGROUND
BACKGROUND
Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare sequela of acute pulmonary embolism that is treatable when recognized. Awareness of this disease has increased with recent advancements in therapeutic options, but delays in diagnosis remain common, and diagnostic and treatment guidelines are often not followed. Data gathered from international registries have improved our understanding of CTEPH, but these data may not be applicable to the US population owing to differences in demographics and medical practice patterns.
OBJECTIVE
OBJECTIVE
The US CTEPH Registry (US-CTEPH-R) was developed to provide essential information to better understand the demographics, risk factors, evaluation, and treatment of CTEPH in the United States, as well as the short- and long-term outcomes of surgical and nonsurgical therapies in the modern treatment era.
METHODS
METHODS
Thirty sites throughout the United States enrolled 750 subjects in this prospective, longitudinal, observational registry of patients newly diagnosed with CTEPH. Enrollment criteria included a mean pulmonary artery pressure ≥25 mmHg by right heart catheterization and radiologic confirmation of CTEPH by a multidisciplinary adjudication committee. Following enrollment, subjects were followed biannually until the conclusion of the study. Quality of life surveys were administered at enrollment and biannually, and all other testing was at the discretion of the treating clinician. Details regarding surgical therapy, balloon pulmonary angioplasty, and medical therapy were collected at enrollment and at follow-up, as well as information related to health care utilization and survival.
RESULTS
RESULTS
Data from this registry will improve understanding of the demographics, risk factors, and treatment patterns of patients with CTEPH, and the longitudinal impact of therapies on quality of life, health care utilization, and survival.
CONCLUSIONS
CONCLUSIONS
This manuscript details the methodology and design of the first large, prospective, longitudinal registry of patients with CTEPH in the United States.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT02429284; https://www.clinicaltrials.gov/ct2/show/NCT02429284.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
UNASSIGNED
DERR1-10.2196/25397.
Identifiants
pubmed: 33848258
pii: v10i5e25397
doi: 10.2196/25397
pmc: PMC8188310
doi:
Banques de données
ClinicalTrials.gov
['NCT02429284']
Types de publication
Journal Article
Langues
eng
Pagination
e25397Informations de copyright
©Kim M Kerr, C Greg Elliott, Raymond L Benza, Richard N Channick, Kelly M Chin, R Duane Davis, Sonia Jain, Andrea Z LaCroix, Michael M Madani, Vallerie V McLaughlin, Myung H Park, Victor F Tapson, William R Auger. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 25.05.2021.
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