Ischemic Heart DiseaseCVD RegistryNCT01759225
Registry of Cardiovascular Disease Patients
An observational study of Ischemic Heart Disease and Congestive Heart Failure, run by Maccabi Healthcare Services, Israel at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Heart Disease, Congestive Heart Failure, Peripheral Vascular Disease
- How many people
- 110,000 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 1998to Dec 2100
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Computerized Registry of Cardiovascular Disease Patients
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.
Read the 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.
- Conditions
- Ischemic Heart Disease, Congestive Heart Failure, Peripheral Vascular Disease, Cerebrovascular Disease, Atrial Fibrillation, Cerebrovascular Atherosclerosis
- Keywords
- Registry, Cardiovascular, CVD, Health Maintenance Organization
- Medical subject headings
- Myocardial Ischemia, Heart Failure, Peripheral Vascular Diseases, Cerebrovascular Disorders, Atrial Fibrillation, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular Disease Patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Cardiovascular disease
Measured: Up to 100 years
Secondary outcomes (4)
prevalence rates of CVD
Measured: up to 100 years
Major Adverse Cardiac Events
Measured: up to 100 years
Number of LDL Tests performed reaching target LDL
Measured: up to 100 years
Proportion of dyslipidemia patients treated with Statins
Measured: up to 100 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startJan 1998
- Primary completionDec 2100 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 110,000 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Maccabi Healthcare Services, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriel Chodick, PHD, Study director, Head,Epidemiology & Database Reseaech Unit, Medical Division, Maccabi H.S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759225
- Sponsor's protocol ID
- MACCVREG1
- Other IDs
- cvdregistry
- Acronym
- CVD Registry
- Status last verified
- Dec 2012
- First submitted
- 18 Dec 2012
- Last updated
- 3 Jan 2013
- Results posted
- No
Publications
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.
PubMed 20826019
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Registry of Cardiovascular Disease Patients
- ClinicalTrials.gov ID
- NCT01759225
- Acronym / sponsor ID
- CVD Registry / MACCVREG1
- Conditions
- Ischemic Heart Disease, Congestive Heart Failure, Peripheral Vascular Disease, Cerebrovascular Disease, Atrial Fibrillation, Cerebrovascular Atherosclerosis
- Keywords
- Registry, Cardiovascular, CVD, Health Maintenance Organization
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 110,000 participants (estimated)
- Lead sponsor
- Maccabi Healthcare Services, IsraelUniversity, hospital or other
- Study start
- Jan 1998
- Primary completion
- Dec 2100 (estimated)
- First posted
- 3 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular Disease Patients | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Patients with Cardiovascular disease
Time frame: Up to 100 years
4 secondary outcomes
prevalence rates of CVD
Time frame: up to 100 years
Major Adverse Cardiac Events
Time frame: up to 100 years
Number of LDL Tests performed reaching target LDL
Time frame: up to 100 years
Proportion of dyslipidemia patients treated with Statins
Time frame: up to 100 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
- Results publication: PubMed 20826019Shalev 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gabriel Chodick, PHD study director
Head,Epidemiology & Database Reseaech Unit, Medical Division, Maccabi H.S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease and Congestive Heart Failure, run by Maccabi Healthcare Services, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients with Cardiovascular disease (time frame: Up to 100 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01759225, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2013.