Clinical trial NCT01759225: Registry of Cardiovascular Disease Patients
Official title: Computerized Registry of Cardiovascular Disease Patients
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Ischemic Heart Disease
Congestive Heart Failure
Peripheral Vascular Disease
Cerebrovascular Disease
Atrial Fibrillation
Cerebrovascular Atherosclerosis
Keywords: Registry, Cardiovascular, CVD, Health Maintenance Organization
Lead sponsor: Maccabi Healthcare Services, Israel
Sponsor class: OTHER
First posted: 2013-01-03
Enrollment: 110000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The electronic registry includes all patients that had been diagnosed twice or more by hospital or outpatient cardiologists, primary physicians, or pediatricians with at least one of the following clinical diagnoses, classified according to the International Classification of Diseases, Ninth revision (ICD-9) codes: Ischemic Heart Disease,MI,non-MI,congestive heart failure,peripheral vascular disease, cerebrovascular disease CVA,TIA, Patients with prior coronary artery bypass grafting(CABG) or percutaneous coronary intervention (PCI), using relevant Current Procedural Terminology (CPT) codes were also included in the registry.

Brief summary: A computerized registry of cardiovascular disease patients in a large health maintenance organization in Israel. The registry is aimed to be used by health professionals to identify cardiovascular disease patients and to follow the courses of their illnesses and risk factors.

Detailed description: The registry was initiated in 1998 by Maccabi Healthcare services, which is the second largest publicly funded HMO in Israel,serving 24% of the total population with a nationwide distribution.

The registry uses advanced information technology that integrates personal computerized community and hospital records, data from laboratory tests, dispensed medications, physiological signals, radiological images, and reports from investigations and procedures.

Eligibility criteria: Inclusion Criteria:

* Clinical Diagnosis of the following:

Ischemic Heart Disease,MI,non-MI,congestive heart failure,peripheral vascular disease, cerebrovascular disease CVA,TIA,patients with first AMI diagnosis from community physicians if they were hospitalized for lasting at least 3 days during a 30-day period prior to diagnosis.

* Patients with prior coronary artery bypass grafting(CABG) or percutaneous coronary intervention (PCI), using relevant Current Procedural Terminology (CPT) codes

Exclusion Criteria:

* patients who were diagnosed as suffering from CHD by primary physician or general hospitals prior to 2000 with no further indication
* Patients whose primary physician reported that the patient is CHD-free providing adequate medical records

Primary outcomes:
measure: Number of Patients with Cardiovascular disease
timeFrame: Up to 100 years
Secondary outcomes:
measure: prevalence rates of CVD
timeFrame: up to 100 years
measure: Major Adverse Cardiac Events
timeFrame: up to 100 years
measure: Number of LDL Tests performed reaching target LDL
timeFrame: up to 100 years
measure: Proportion of dyslipidemia patients treated with Statins
timeFrame: up to 100 years
Other outcomes:
measure: hospitalization days due to CVD
timeFrame: up to 100 years
Locations:
city: Tel Aviv
country: Israel
facility: Maccabi Healthcare Services
Study officials:
affiliation: Head,Epidemiology & Database Reseaech Unit, Medical Division, Maccabi H.S
name: Gabriel Chodick, PHD
role: STUDY_DIRECTOR
References:
citation: Shalev V, Chodick G, Goren I, Silber H, Kokia E, Heymann AD. The use of an automated patient registry to manage and monitor cardiovascular conditions and related outcomes in a large health organization. Int J Cardiol. 2011 Nov 3;152(3):345-9. doi: 10.1016/j.ijcard.2010.08.002. Epub 2010 Sep 9.