Persian Registry Of cardioVascular diseasE (PROVE): Design and methodology

Mahshid Givi; Nizal Sarrafzadegan; Mohammad Garakyaraghi; Ghasem Yadegarfar; Masoumeh Sadeghi; Alireza Khosravi; Amir Hossein Azhari; Mohammad Reza Samienasab; Davood Shafie; Mohammad Saadatnia; Hamidreza Roohafza; Navid Paydari; Azam Soleimani; Mohsen Hosseinzadeh; Seyed Abdulah Ahmadi; Leila Dehghani; Jamshid Najafian; Elham Andalib; Javad Shahabi; Mohammad Reza Sabri

Persian Registry Of cardioVascular diseasE (PROVE): Design and methodology

ARYA Atheroscler. 2017 Sep;13(5):236-244.

Authors

Mahshid Givi¹, Nizal Sarrafzadegan², Mohammad Garakyaraghi¹, Ghasem Yadegarfar³, Masoumeh Sadeghi⁴, Alireza Khosravi⁵, Amir Hossein Azhari¹, Mohammad Reza Samienasab², Davood Shafie¹, Mohammad Saadatnia⁶, Hamidreza Roohafza², Navid Paydari², Azam Soleimani⁴, Mohsen Hosseinzadeh⁷, Seyed Abdulah Ahmadi², Leila Dehghani⁸, Jamshid Najafian², Elham Andalib², Javad Shahabi¹, Mohammad Reza Sabri⁷

Affiliations

¹ Heart Failure Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.
² Isfahan Cardiovascular Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.
³ Heart Failure Research Center, Cardiovascular Research Institute AND Department of Epidemiology and Biostatic, School of Public Health, Isfahan University of Medical Sciences, Isfahan, Iran.
⁴ Cardiac Rehabilitation Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.
⁵ Hypertension Research Center AND Cardiac Intervention Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.
⁶ Isfahan Neurosciences Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.
⁷ Pediatric Cardiovascular Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.
⁸ School of Advanced Technologies in Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

PMID: 29371870
PMCID: PMC5774796

Abstract

Background: Our aim was to create and establish a database called "Persian Registry Of cardioVascular diseasE (PROVE)" in order to be used for future research and in addition, as a tool to develop national guidelines for diagnosis, treatment, and prevention of cardiovascular disease (CVD). In this paper, the design and methodology of the PROVE pilot study will be discussed, launched in Isfahan, Iran, in 2015-2016.

Methods: Through establishing PROVE, patients' data were collected from hospitals and outpatient clinics prospectively or retrospectively and followed up for a maximum of three years based on the type of CVDs. The inclusion criteria were as patients with acute coronary syndrome (ACS), ST elevation myocardial infarction (STEMI), stroke, atrial fibrillation (AF), heart failure (HF), congenital heart disease (CHD), percutaneous coronary intervention (PCI), and chronic ischemic cardiovascular disease (CICD). Specific protocols, questionnaires, and glossaries were developed for each registry. In order to ensure the validation of the protocols, questionnaires, data collection, management, and analysis, a well-established quality control (QC) protocol was developed and implemented. Data confidentiality was considered.

Results: In order to register patients with ACS, STEMI, stroke, HF, PCI, and CICD, the hospital recorded data were used, whereas, in case of AF and CHD registries, the data were collected from hospitals and outpatient clinics. During the pilot phase of the study in Isfahan, from March 2015 to September 2016, 9427 patients were registered as ACS including 809 as STEMI, 1195 patients with HF, 363 with AF, 761 with stroke, 1136 with CHD, 1200 with PCI, and 9 with CICD. Data collection and management were performed under the supervision of the QC group.

Conclusion: PROVE was developed and implemented in Isfahan as a pilot study, in order to be implemented at national level in future. It provides a valuable source of valid data that could be used for future research, re-evaluation of current CVD management and more specifically, gap analysis and as a tool for assessment of the type of CVDs, prevention, treatment, and control by health care decision makers.

Keywords: Cardiovascular Disease; Data Collection; Disease Management; Registries.