Coronary ArteriosclerosisNCT00394680
Stents, Drug Eluting Stents, and CABG- Financial and Clinical Impact.
An observational study of Coronary Arteriosclerosis and Angina Unstable, run by Shaare Zedek Medical Center.
Trial summary
Options for coronary revascularization include stent implantation and coronary bypass surgery. Both modalities have their unique advantages and disadvantages in terms of clinical outcomes as well as financial impact on the medical system. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Arteriosclerosis, Angina Unstable, Myocardial Infarction
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to May 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients which are insured in the relevant HMO's and suffer from a multi-vessel coronary disease and were treated during 2000-2004
Who may be able to join
- Patients which are insured in the relevant HMO's and suffer from a multi-vessel coronary disease with occlusion of at least 70% of at least two of the main coronary vessels.
Who cannot join
- Non multi- vessel Disease
- Any additional cardiac disease
- Valvular
- Low EF (<30%)
- Liver disease - according to liver enzymes
- Other cardiac treatment (past or immediate future)
- Active MI (24hrs before revascularization)
- Previous revascularization before beginning of follow up.
About this study
Options for coronary revascularization include stent implantation and coronary bypass surgery. Both modalities have their unique advantages and disadvantages in terms of clinical outcomes as well as financial impact on the medical system. We wish to investigate the late results of patients undergoing coronary revascularization, the need for re-hospitalization, re-intervention, patient satisfaction as well as the financial burden on the medical system. The study will be conducted by historical prospective review of hospital records in conjunction with records of the medical insurance companies ("HMO's").
Read the detailed description
Cardio-vascular disease is the second leading cause of death in the western world. Two modes of treatment are currently used:
Coronary Artery Bypass Graft (CABG) Percutaneous Interventions (PCIs) i.e: balloon angioplasty and stents[ bare metal (BMS) and drug eluting (DES)].
CABG is a major operation but is considered to be safe and with good quality of life in the years to follow. The initial cost of CABG is high but usually stays low thereafter.
PCI is less invasive but its downfall is a high rate of restenosis hence leading to the return of angina. The initial cost is low but due to the return of symptoms the cost increases.
The goal of DES is to lower the rate of restenosis thus reducing the need for repeat hospitalizations and procedures. The initial cost of this stent is higher than that of the BMS but still lower than that of CABG.
The goal of this study is to assess and compare the average annual cost of treatment for patients with multi-vessel disease who underwent one of the following procedures:
- CABG
- DES
- BMS
The information for the study is derived from the data bases of the cardiology and cardio-thoracic surgery departments at Shaarey-Zedek hospital and from those of Clalit Health Services and Kupat Holim Meuhedet.
The study design is historical prospective. The participants are insured by the above mentioned HMOs and were treated during 2000-2004.
The final sample's size will be decided on according to a pilot study with 15 patients from each of the treatment groups.
To our knowledge no studies comparing CABG and DES have yet been published. We believe that our study could become a mile stone in the process of choosing the most suitable treatment for the patient and for the health system.
- Keywords
- coronary revascularization, stent inmplantation, coronary bypass
- Medical subject headings
- Coronary Artery Disease, Angina, Unstable, Myocardial Infarction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2006 (estimated)
- Study startNov 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary ArteriosclerosisStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Investigators
- Amir Shmueli, PhD, Principal investigator, The Hebrew University, School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394680
- Sponsor's protocol ID
- CABGvsStent-Jerusalem
- Status last verified
- May 2011
- First submitted
- 31 Oct 2006
- Last updated
- 27 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stents, Drug Eluting Stents, and CABG- Financial and Clinical Impact.
- ClinicalTrials.gov ID
- NCT00394680
- Acronym / sponsor ID
- CABGvsStent-Jerusalem
- Keywords
- coronary revascularization, stent inmplantation, coronary bypass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Study start
- Nov 2006
- Study completion
- May 2007 (actual)
- First posted
- 1 Nov 2006 (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.
Options for coronary revascularization include stent implantation and coronary bypass surgery. Both modalities have their unique advantages and disadvantages in terms of clinical outcomes as well as financial impact on the medical system. We wish to investigate the late results of patients undergoing coronary revascularization, the need for re-hospitalization, re-intervention, patient satisfaction as well as the financial burden on the medical system. The study will be conducted by historical prospective review of hospital records in conjunction with records of the medical insurance companies ("HMO's").
Detailed description
Cardio-vascular disease is the second leading cause of death in the western world. Two modes of treatment are currently used:
Coronary Artery Bypass Graft (CABG) Percutaneous Interventions (PCIs) i.e: balloon angioplasty and stents[ bare metal (BMS) and drug eluting (DES)].
CABG is a major operation but is considered to be safe and with good quality of life in the years to follow. The initial cost of CABG is high but usually stays low thereafter.
PCI is less invasive but its downfall is a high rate of restenosis hence leading to the return of angina. The initial cost is low but due to the return of symptoms the cost increases.
The goal of DES is to lower the rate of restenosis thus reducing the need for repeat hospitalizations and procedures. The initial cost of this stent is higher than that of the BMS but still lower than that of CABG.
The goal of this study is to assess and compare the average annual cost of treatment for patients with multi-vessel disease who underwent one of the following procedures:
- CABG
- DES
- BMS
The information for the study is derived from the data bases of the cardiology and cardio-thoracic surgery departments at Shaarey-Zedek hospital and from those of Clalit Health Services and Kupat Holim Meuhedet.
The study design is historical prospective. The participants are insured by the above mentioned HMOs and were treated during 2000-2004.
The final sample's size will be decided on according to a pilot study with 15 patients from each of the treatment groups.
To our knowledge no studies comparing CABG and DES have yet been published. We believe that our study could become a mile stone in the process of choosing the most suitable treatment for the patient and for the health system.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients which are insured in the relevant HMO's and suffer from a multi-vessel coronary disease and were treated during 2000-2004
Key inclusion criteria (1 listed)
- Patients which are insured in the relevant HMO's and suffer from a multi-vessel coronary disease with occlusion of at least 70% of at least two of the main coronary vessels.
Key exclusion criteria (8 listed)
- Non multi- vessel Disease
- Any additional cardiac disease
- Liver disease - according to liver enzymes
- Other cardiac treatment (past or immediate future)
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2011.
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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. This study is not recruiting at the moment.
Amir Shmueli, PhD principal investigator
The Hebrew University, School of Public Health
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Arteriosclerosis and Angina Unstable, run by Shaare Zedek Medical Center.
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 27 May 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 27 May 2011.