RDG README File Template --- General --- Version: 0.1 (2022-10-04)
This README file was generated on [2023-07-25] by [Allix-Béguec Caroline].
Last updated: [2023-10-24].
# GENERAL INFORMATION
## Dataset title:
Long-term effectiveness of a stent-less strategy in patients with coronary artery disease: 3-year follow-up of a prospective all-comers observational study (SCRAP3y)
## DOI:
10.5281/zenodo.8182420
## Contact email:
recherche.clinique@ght-atlantique17.fr
# METHODOLOGICAL INFORMATION
## Environmental/experimental conditions:
Cohort study
## Description of sources and methods used to collect and generate data:
Data were collected from medical records and follow-up at one and three years
## Methods for processing the data:
*CardioReport has generated the initial database.
*A code was used for each patient consisting of the first letter of the surname and first name, followed by a number.
*Follow-up data were collected on Excel by a study site coordinator.
## Quality -assurance procedures performed on the data:
*Inclusion criteria, primary and secondary outcomes were monitored by clinical research assistants.
*In case of inconsistencies, queries were sent to the study site coordinator for confirmation or correction.
*Before closing the database, outliers were detected by the statistician and queries were sent to the study site coordinator for confirmation or correction.
# DATA & FILE OVERVIEW
## File naming convention:
date_file content_version.extension
# DATA-SPECIFIC INFORMATION FOR: 230203_Data_V01.csv
## Variable/Column List:
For each variable or column name :
-- full “human readable” name of the variable,
-- description of the variable,
-- unit of measurement if applicable,
-- decimal separator *i.e.* comma or point if applicable
-- allowed values : list of values or range, or domain
-- format if applicable, e.g. date>
* -- ID Patient
-- Patient unique key
--
--
--
-- Text
* -- Sex
--
--
--
-- 1:female ; 2:male
-- Option
* -- Age
--
-- year
--
--
-- Number
* -- BMI
-- Body mass index
-- kg/m2
-- point
--
-- Number
* -- Family history of CAD
-- Family history of coronary artery disease
--
--
-- 0:no history ; 1:history
-- Option
* -- Diabetes
--
--
--
-- 0:no diabetes ; 1:diabetes
-- Option
* -- Hypertension
-- Hypertension arterial
--
--
-- 0:no hypertension ; 1:hypertension
-- Option
* -- Smoking
-- Tobacco use
--
--
-- 0:non-tobacco user ; 1:tobacco user ; 2:ex-tobacco user
-- Option
* -- History of revascularization
-- History of coronary revascularization
--
--
-- 0:no history ; 1:history
-- Option
* -- Bypass
-- History of arterial bypass operation
--
--
-- 0:no history ; 1:history
-- Option
* -- History of myocardial infarction
--
--
--
-- 0:no history ; 1:history
-- Option
* -- History of stroke
--
--
--
-- 0:no history ; 1:history
-- Option
* -- Peripheral arterial occlusive disease
-- History of peripheral arterial occlusive disease
--
--
-- 0:no history ; 1:history
-- Option
* -- LVEF
-- Left ventricular ejection fraction
--
--
-- 1:≥ 50% ; 2:35-50% ; 3:≤ 35%
-- Option
* -- Indication
-- Type of cardiac disorder
--
--
-- 1:STEMI ; 2: Non STEMI ; 3:chronic coronary syndrom
-- Option
* -- Angioplasty strategy
--
--
--
-- 1: conventional-DES; 2: BO-DES; 3: DCB only
-- Option
* -- One year follow-up
-- Type of contact with the patients
--
--
-- 0:Lost to follow-up ; 1:phone ; 2:in-hospital ; 3:consultation ; 4:deceased
-- Option
* -- Lost to follow-up reason
--
--
--
--
-- Text
* -- ASA
-- acetyl salicilic acid
--
--
-- 0:no ; 1:yes
-- Option
* -- APA
-- anti-platelet agent
--
--
-- 0:no ; 1:yes
-- Option
* -- ACO
-- anticoagulant
--
--
-- 0:no ; 1:yes
-- Option
* -- MACE
-- Major adverse cardiac event
--
--
-- 0:no ; 1:yes
-- Option
* -- Type of MACE
--
--
--
-- 0:no event ; 1:Coronary revascularization ; 2:non-fatal stroke ; 3:non-fatal myocardial infarction ; 4:death (all causes)
-- Option
* -- Comment
--
--
--
--
-- Text
* -- 3-year follow-up
-- Type of contact with the patients
--
--
-- 0:Lost to follow-up ; 1:phone ; 2:in-hospital ; 3:consultation ; 4:deceased; 5:consent withdrawal
-- Option
* -- MACE 3-year follow-up
-- Major adverse cardiac event that happened between 1 and 3 years after the procedure
--
--
-- 0:no ; 1:yes
-- Option
* -- Type of MACE 1
--
--
--
-- 0:no event ; 1:Coronary revascularization ; 2:non-fatal stroke ; 3:non-fatal myocardial infarction ; 4:death (all causes)
-- Option
* -- Type of MACE 2
--
--
--
-- 0:no event ; 1:Coronary revascularization ; 2:non-fatal stroke ; 3:non-fatal myocardial infarction ; 4:death (all causes)
-- Option
* -- N MACE
-- Number of MACE
--
--
--
-- Number
* -- ISR/TLR
-- lesion revascularization
--
--
-- 1:intra-stent revascularization; 2:target lesion revascularization after DCB; 3:ISR+TLR
-- Option
* -- ASA at 3-year follow-up
-- acetyl salicilic acid
--
--
-- 0:no ; 1:yes
-- Option
* -- APA at 3-year follow-up
-- anti-platelet agent
--
--
-- 0:no ; 1:yes
-- Option
* -- ACO at 3-year follow-up
-- anticoagulant
--
--
-- 0:no ; 1:yes
-- Option
* -- Covid-19
-- confirmed by PCR within the 3-year follow-up
--
--
-- 0:no ; 1:yes
-- Option
* -- Time to 1-year MACE
--
-- months
--
--
-- Number
* -- Time to 3-year MACE 1
--
-- months
--
--
-- Number
* -- Time to 3-year MACE 2
--
-- months
--
--
-- Number
* -- Time to last follow-up
--
-- months
--
--
-- Number
## Missing data codes:
Blank for missing data
NA for non applicable
