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
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