Registry of Cardiovascular Disease Patients (CVD Registry)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Maccabi Healthcare Services, Israel
ClinicalTrials.gov Identifier:
NCT01759225
First received: December 18, 2012
Last updated: December 27, 2012
Last verified: December 2012
  Purpose

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.


Condition
Ischemic Heart Disease
Congestive Heart Failure
Peripheral Vascular Disease
Cerebrovascular Disease
Atrial Fibrillation
Cerebrovascular Atherosclerosis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration: 1 Month
Official Title: Computerized Registry of Cardiovascular Disease Patients

Resource links provided by NLM:


Further study details as provided by Maccabi Healthcare Services, Israel:

Primary Outcome Measures:
  • Number of Patients with Cardiovascular disease [ Time Frame: Up to 100 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • prevalence rates of CVD [ Time Frame: up to 100 years ] [ Designated as safety issue: No ]
  • Major Adverse Cardiac Events [ Time Frame: up to 100 years ] [ Designated as safety issue: No ]
  • Number of LDL Tests performed reaching target LDL [ Time Frame: up to 100 years ] [ Designated as safety issue: No ]
  • Proportion of dyslipidemia patients treated with Statins [ Time Frame: up to 100 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • hospitalization days due to CVD [ Time Frame: up to 100 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 110000
Study Start Date: January 1998
Estimated Primary Completion Date: December 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cardiovascular Disease Patients

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01759225

Locations
Israel
Maccabi Healthcare Services
Tel Aviv, Israel, 68125
Sponsors and Collaborators
Maccabi Healthcare Services, Israel
Investigators
Study Director: Gabriel Chodick, PHD Head,Epidemiology & Database Reseaech Unit, Medical Division, Maccabi H.S
  More Information

Additional Information:
Publications:
Responsible Party: Maccabi Healthcare Services, Israel
ClinicalTrials.gov Identifier: NCT01759225     History of Changes
Other Study ID Numbers: MACCVREG1, cvdregistry
Study First Received: December 18, 2012
Last Updated: December 27, 2012
Health Authority: United States:Department of Health and Human Services

Keywords provided by Maccabi Healthcare Services, Israel:
Registry, Cardiovascular, CVD, Health Maintenance Organization

Additional relevant MeSH terms:
Atherosclerosis
Atrial Fibrillation
Cardiovascular Diseases
Cerebrovascular Disorders
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Heart Failure
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Arteriosclerosis
Arterial Occlusive Diseases
Arrhythmias, Cardiac
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Coronary Disease

ClinicalTrials.gov processed this record on July 20, 2014