Ischemic Heart DiseaseNCT00392964
Patterns of Antiacids Use in Patients With IHD Admitted to Department of Internal Medicine
An observational study of Ischemic Heart Disease, run by Rambam Health Care Campus at 2 sites in Israel.
Trial summary
There is substantial, continuing, and unexplained rise in prescribing of proton pump inhibitors. It is unknown whether their use in practice has corresponded to their licensed indications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease
- How many people
- 1,200 participants
- Where
- 2 sitesIsrael
- Study dates
- Jan 2006to Nov 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic Heart Disease
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Rambam: Health Care Campus
Haifa, 31096
Rambam Health Care Campus
Haifa
About this study
There is substantial, continuing, and unexplained rise in prescribing of proton pump inhibitors. It is unknown whether their use in practice has corresponded to their licensed indications.
Although the indications for H2RA or PPI administration in the treatment of acid-related diseases and the prevention of gastric mucosal damage have been well defined in the medical literature, the perception of benefit from their use frequently tends to be extrapolated to all patients in general, leading to an excessive consumption of these drugs in general practice.
Read more
To date, however, little has been published with regard to the overall use or misuse of these drugs in hospital populations in ischemic heart disease patients as a secondary prevention to Aspirin use.
We will undertake a 6-months retrospective survey (about 1200 patients) to evaluate the use of acid-suppressive medications in the general internal medicine ward of Rambam Hospital.
We will extract all records of prescribing of a proton pump inhibitor within Rambam Hospital computerized patients file program (Premetheuos) in period of half year, categorized and analyze them using statistical X2 test.
Read the detailed description
Dyspeptic symptoms are a common presenting complaint, and there is continuing debate about management. Acid suppressant drugs, the most potent of which are proton pump inhibitors, are often prescribed, and it has been suggested that proton pump inhibitors are probably too widely prescribed for minor symptoms, and the cost implications of this are clear. There is substantial, continuing, and unexplained rise in prescribing of proton pump inhibitors. It is unknown whether their use in practice has corresponded to their licensed indications.
Although the indications for H2RA or proton pump inhibitor administration in the treatment of acid-related diseases and the prevention of gastric mucosal damage have been well defined in the medical literature, the perception of benefit from their use frequently tends to be extrapolated to all patients in general, leading to an excessive consumption of these drugs in general practice.
In addition, Physicians, nowadays tend to prescribe proton pump inhibitors for cardiac patients who use aspirin as secondary prevention of their illness.
To date, however, little has been published with regard to the overall use or misuse of these drugs in hospital populations, or to the fall-out of hospital prescriptions in general practice and none has been published regarding its use in ischemic heart disease patients as a secondary prevention to Aspirin use.
We will undertake a 6-months retrospective survey (about 1200 patients) to evaluate the use of acid-suppressive medications in the general internal medicine ward of Rambam Hospital, a large teaching hospital in Northern Israel; as well as the appropriateness of their prescription to the licensed indications, while dividing them to subgroups of ischemic heart disease patients.
We will extract all records of prescribing of a proton pump inhibitor within Rambam Hospital computerized patients file program (Premetheuos) in period of half year, categorized and analyze them using statistical X2 test.
- Conditions
- Ischemic Heart Disease
- Keywords
- Antacids, Proton pump inhibitors, aspirin, ischemic heart disease, Dyspepsia
- Medical subject headings
- Myocardial Ischemia, Dyspepsia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2006 (estimated)
- Study startJan 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Defined population
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Investigators
- Zaher S Azzam, MD, Principal investigator, Acting Director of Internal Medicine "B"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00392964
- Sponsor's protocol ID
- ZSA2438CTIL
- Status last verified
- Apr 2007
- First submitted
- 25 Oct 2006
- Last updated
- 11 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns of Antiacids Use in Patients With IHD Admitted to Department of Internal Medicine
- ClinicalTrials.gov ID
- NCT00392964
- Acronym / sponsor ID
- ZSA2438CTIL
- Conditions
- Ischemic Heart Disease
- Keywords
- Antacids, Proton pump inhibitors, aspirin, ischemic heart disease, Dyspepsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Nov 2006 (actual)
- First posted
- 26 Oct 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.
There is substantial, continuing, and unexplained rise in prescribing of proton pump inhibitors. It is unknown whether their use in practice has corresponded to their licensed indications.
Although the indications for H2RA or PPI administration in the treatment of acid-related diseases and the prevention of gastric mucosal damage have been well defined in the medical literature, the perception of benefit from their use frequently tends to be extrapolated to all patients in general, leading to an excessive consumption of these drugs in general practice.
To date, however, little has been published with regard to the overall use or misuse of these drugs in hospital populations in ischemic heart disease patients as a secondary prevention to Aspirin use.
We will undertake a 6-months retrospective survey (about 1200 patients) to evaluate the use of acid-suppressive medications in the general internal medicine ward of Rambam Hospital.
We will extract all records of prescribing of a proton pump inhibitor within Rambam Hospital computerized patients file program (Premetheuos) in period of half year, categorized and analyze them using statistical X2 test.
Detailed description
Dyspeptic symptoms are a common presenting complaint, and there is continuing debate about management. Acid suppressant drugs, the most potent of which are proton pump inhibitors, are often prescribed, and it has been suggested that proton pump inhibitors are probably too widely prescribed for minor symptoms, and the cost implications of this are clear. There is substantial, continuing, and unexplained rise in prescribing of proton pump inhibitors. It is unknown whether their use in practice has corresponded to their licensed indications.
Although the indications for H2RA or proton pump inhibitor administration in the treatment of acid-related diseases and the prevention of gastric mucosal damage have been well defined in the medical literature, the perception of benefit from their use frequently tends to be extrapolated to all patients in general, leading to an excessive consumption of these drugs in general practice.
In addition, Physicians, nowadays tend to prescribe proton pump inhibitors for cardiac patients who use aspirin as secondary prevention of their illness.
To date, however, little has been published with regard to the overall use or misuse of these drugs in hospital populations, or to the fall-out of hospital prescriptions in general practice and none has been published regarding its use in ischemic heart disease patients as a secondary prevention to Aspirin use.
We will undertake a 6-months retrospective survey (about 1200 patients) to evaluate the use of acid-suppressive medications in the general internal medicine ward of Rambam Hospital, a large teaching hospital in Northern Israel; as well as the appropriateness of their prescription to the licensed indications, while dividing them to subgroups of ischemic heart disease patients.
We will extract all records of prescribing of a proton pump inhibitor within Rambam Hospital computerized patients file program (Premetheuos) in period of half year, categorized and analyze them using statistical X2 test.
Study design
- Observational model
- Defined population
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ischemic Heart Disease
Key exclusion criteria (0 listed)
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 11 Apr 2007.
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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.
Zaher S Azzam, MD principal investigator
Acting Director of Internal Medicine "B"
2 sites 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, run by Rambam Health Care Campus at 2 sites 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 1 inclusion and 0 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 11 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 11 Apr 2007.