The study protocol for a non-randomized controlled clinical trial using a genotype-guided strategy in a dataset of patients who undergone percutaneous coronary intervention with stent
Autor: | Susana Martínez Huertas, Mª Carmen Marín Guzmán, Luis Javier Martinez-Gonzalez, Pablo Toledo Frías, Cristina Lucía Dávila-Fajardo, José Cabeza Barrera, Xando Diaz Villamarín, F. Gomez, José Antonio Ramirez Hernández, Alicia Bautista Pavés, Jesús Sánchez-Ramos, Juan Caballero Borrego, Concepción Correa Vilches |
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Přispěvatelé: | [Lucia Davila-Fajardo, Cristina] Granada Univ Hosp, Ibs, Inst Biomed Res, Dept Clin Pharm, Granada, Spain, [Diaz-Villamarin, Xando] Granada Univ Hosp, Ibs, Inst Biomed Res, Dept Clin Pharm, Granada, Spain, [Ramirez Hernandez, Jose Antonio] Granada Univ Hosp, Ibs, Inst Biomed Res, Dept Clin Pharm, Granada, Spain, [Cabeza Barrera, Jose] Granada Univ Hosp, Ibs, Inst Biomed Res, Dept Clin Pharm, Granada, Spain, [Sanchez-Ramos, Jesus] Granada Univ Hosp, Ibs, Inst Biomed Res, Dept Cardiol, Granada, Spain, [Toledo Frias, Pablo] Granada Univ Hosp, Ibs, Inst Biomed Res, Dept Cardiol, Granada, Spain, [Martinez Huertas, Susana] Granada Univ Hosp, Ibs, Inst Biomed Res, Dept Cardiol, Granada, Spain, [Burillo Gomez, Francisco] Granada Univ Hosp, Ibs, Inst Biomed Res, Dept Cardiol, Granada, Spain, [Caballero Borrego, Juan] Granada Univ Hosp, Ibs, Inst Biomed Res, Dept Cardiol, Granada, Spain, [Bautista Paves, Alicia] Granada Univ Hosp, Ibs, Inst Biomed Res, Dept Cardiol, Granada, Spain, [Marin Guzman, Ma Carmen] Granada Univ Hosp, Ibs, Inst Biomed Res, Dept Cardiol, Granada, Spain, [Correa Vilches, Concepcion] Granada Univ Hosp, Ibs, Inst Biomed Res, Dept Cardiol, Granada, Spain, [Javier Martinez-Gonzalez, Luis] Univ Granada, Andalusian Reg Govt, Ctr Genom & Oncol Res GENYO, Genom Unit, Hlth Sci Technol Pk, Granada, Spain, Ministry of Health of Government of Andalusia, [Dávila-Fajardo,CL, Diaz- Villamarín,X, Ramirez Hernández,JA, Cabeza Barrera,J] Department of Clinical Pharmacy, Granada University Hospital. [Sánchez-Ramos,J, Toledo Frías,P, Martínez Huertas,S, Burillo Gómez,F, Caballero Borrego,J, Bautista Pavés,A, Marín Guzmán,MC, Correa Vilches,C] Department of Cardiology, Granada University Hospital. [Dávila-Fajardo,CL, Cabeza Barrera,J, Sánchez-Ramos,J, Correa Vilches,C] Institute for Biomedical Research, ibs., Granada, Spain. [Martínez-González,LJ] Genomics Unit, Centre for Genomics and Oncological Research (GENYO), Pfizer-University of Granada-Andalusian Regional Government, Health Sciences Technology Park, Granada, Spain., This work was supported by Ministry of Health of Government of Andalusia, Grant number: PI-057/2012. |
Rok vydání: | 2017 |
Předmět: |
0301 basic medicine
medicine.medical_specialty Analytical Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Research Design::Sample Size [Medical Subject Headings] Tamaño de la muestra medicine.medical_treatment Analytical Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Diagnostic Imaging::Tomography::Tomography X-Ray::Tomography X-Ray Computed [Medical Subject Headings] 030204 cardiovascular system & hematology lcsh:Computer applications to medicine. Medical informatics Diseases::Pathological Conditions Signs and Symptoms::Pathologic Processes::Hemorrhage [Medical Subject Headings] Chemicals and Drugs::Enzymes and Coenzymes::Cytochromes [Medical Subject Headings] Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings] Analytical Diagnostic and Therapeutic Techniques and Equipment::Equipment and Supplies::Prostheses and Implants::Stents [Medical Subject Headings] 03 medical and health sciences 0302 clinical medicine Hemorragia Analytical Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Cohort Studies::Longitudinal Studies::Follow-Up Studies [Medical Subject Headings] medicine Analytical Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Clinical Protocols [Medical Subject Headings] Tomografía computarizada por rayos x Chemicals and Drugs::Amino Acids Peptides and Proteins::Proteins::Glycoproteins::Membrane Glycoproteins::ATP-Binding Cassette Transporters::P-Glycoproteins [Medical Subject Headings] lcsh:Science (General) Data Article Glicoproteínas p Protocol (science) Multidisciplinary business.industry Clinical trial protocol General surgery Analytical Diagnostic and Therapeutic Techniques and Equipment::Surgical Procedures Operative::Cardiovascular Surgical Procedures::Vascular Surgical Procedures::Endovascular Procedures::Percutaneous Coronary Intervention [Medical Subject Headings] Stent Percutaneous coronary intervention Intervención coronaria percutánea Formularios de consentimiento Surgery Clinical trial 030104 developmental biology Sample size determination Conventional PCI Inclusion and exclusion criteria Protocolos clínicos Citocromos lcsh:R858-859.7 Population study Phenomena and Processes::Genetic Phenomena::Genotype [Medical Subject Headings] Estudios de seguimiento business Genotipo Health Care::Health Care Quality Access and Evaluation::Quality of Health Care::Health Care Evaluation Mechanisms::Data Collection::Records as Topic::Consent Forms [Medical Subject Headings] lcsh:Q1-390 |
Zdroj: | Data in Brief Data in Brief, Vol 10, Iss C, Pp 518-524 (2017) |
ISSN: | 2352-3409 |
DOI: | 10.1016/j.dib.2016.12.019 |
Popis: | This article contains data related to the research article entitled "Results of genotype-guided antiplatelet therapy in patients undergone percutaneous coronary intervention with stent" (J. Sanchez-Ramos, C.L. Davila-Fajardo, P. Toledo Frias, X. Diaz Villamarin, L.J. Martinez-Gonzalez, S. Martinez Huertas, F. Burillo Gomez, J. Caballero Borrego, A. Bautista Paves, M.C. Marin Guzman, J.A. Ramirez Hernandez, C. Correa Vilches, J. Cabeza Barrera, 2016) (1). This data article reports, for the first time, about the non-randomized clinical trial protocol that check if CYP2C19/ABCB1 genotype-guided strategy in which the choice of antiplatelet therapy is based on the genetic test, reduces the rates of cardiovascular events and bleeding compared to a non-tailored strategy in patients undergone percutaneous coronary intervention (PCI) with stent. The data included in this article are: design and setting of the study, study population, inclusion and exclusion criteria, definition of the intervention, objectives, variables (baseline characteristics and during the follow-up), study procedures, collection and treatment of the biological sample, genotyping, withdrawal criteria, sample size, statistic analysis, ethical aspects, information sheet and consent form. The authors confirm that this study has been registered in Eudra CT (Eudra CT: 2016-001294-33). (C) 2016 Published by Elsevier Inc. |
Databáze: | OpenAIRE |
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