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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01759225
Other study ID # MACCVREG1
Secondary ID cvdregistry
Status Enrolling by invitation
Phase N/A
First received December 18, 2012
Last updated December 27, 2012
Start date January 1998

Study information

Verified date December 2012
Source Maccabi Healthcare Services, Israel
Contact n/a
Is FDA regulated No
Health authority United States:Department of Health and Human Services
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 110000
Est. completion date
Est. primary completion date December 2100
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective


Locations

Country Name City State
Israel Maccabi Healthcare Services Tel Aviv

Sponsors (1)

Lead Sponsor Collaborator
Maccabi Healthcare Services, Israel

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other hospitalization days due to CVD up to 100 years No
Primary Number of Patients with Cardiovascular disease Up to 100 years No
Secondary prevalence rates of CVD up to 100 years No
Secondary Major Adverse Cardiac Events up to 100 years No
Secondary Number of LDL Tests performed reaching target LDL up to 100 years No
Secondary Proportion of dyslipidemia patients treated with Statins up to 100 years No
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