Myocardial IschemiaIRIDIANCT00224575
Reassessment Strategy in the Diagnosis of Coronary Heart Disease in Elderly
A study testing diagnosis reassessment and Diagnosis strategy and subsequent therapeutic reassessment in people with Myocardial Ischemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Despite the effectiveness of beta-blockers and antiplatelet agents for secondary prevention of coronary heart disease, this treatments are underused in the elderly because of diagnosis uncertainty and underuse of efficient treatment. in a first time, diagnosis reassessment with invasive technique if necessary. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- diagnosis reassessment and Diagnosis strategy and subsequent therapeutic reassessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2004to Nov 2006
- Phase
- Interventional
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patients 75 of age or older hospitalized in a geriatric service and suspect of coronary heart disease
Who cannot join
- acute myocardial infarction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutical Impact of a Reassessment Strategy in the Diagnosis of Coronary Heart Disease in Elderly
Despite the effectiveness of beta-blockers and antiplatelet agents for secondary prevention of coronary heart disease, this treatments are underused in the elderly because of diagnosis uncertainty and underuse of efficient treatment.
in a first time, diagnosis reassessment with invasive technique if necessary. in a second time, treatment reassessment.
Read the detailed description
not desired
- Conditions
- Myocardial Ischemia
- Being tested
- diagnosis reassessment, Diagnosis strategy and subsequent therapeutic reassessment
- Keywords
- Veterans
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnosis reassessmentOther
Also called no other names to specified
Strategy of diagnosis reassessment following a decision tree.
Diagnosis strategy and subsequent therapeutic reassessmentOther
Performed by geriatricians, following a decision tree, based on medical history, electrocardiogram, cardiac echotomography and stress scintigraphy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Diagnosis strategy and subsequent therapeutic reassessment All patients are in that arms. They all receive the diagnosis reassessment strategy. Receives: Other: diagnosis reassessment; Other: Diagnosis strategy and subsequent therapeutic reassessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
therapeutical impact of a reassessment strategy in the diagnosis of coronary heart disease in elderly
Measured: during hospitalization
Secondary outcomes (1)
part link, in the treatment modification, with diagnosis reassessment and the part link with treatment optimization, death and rehospitalization in the subsequent 6 and 12 months
Measured: during hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionNov 2005
- Study completionNov 2006
Why it stopped: End of recruitment period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- legrain sylvie, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00224575
- Sponsor's protocol ID
- AOM03099
- Acronym
- IRIDIA
- Status last verified
- Mar 2016
- First submitted
- 13 Sep 2005
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutical Impact of a Reassessment Strategy in the Diagnosis of Coronary Heart Disease in Elderly
- ClinicalTrials.gov ID
- NCT00224575
- Acronym / sponsor ID
- IRIDIA / AOM03099
- Conditions
- Myocardial Ischemia
- Keywords
- Veterans
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: End of recruitment period
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 23 Sep 2005 (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.
Despite the effectiveness of beta-blockers and antiplatelet agents for secondary prevention of coronary heart disease, this treatments are underused in the elderly because of diagnosis uncertainty and underuse of efficient treatment.
in a first time, diagnosis reassessment with invasive technique if necessary. in a second time, treatment reassessment.
Detailed description
not desired
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: diagnosis reassessment, Other: Diagnosis strategy and subsequent therapeutic reassessmentDiagnosis strategy and subsequent therapeutic reassessment All patients are in that arms. They all receive the diagnosis reassessment strategy. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- patients 75 of age or older hospitalized in a geriatric service and suspect of coronary heart disease
Key exclusion criteria (1 listed)
- acute myocardial infarction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diagnosis reassessmentAlso: no other names to specifiedStrategy of diagnosis reassessment following a decision tree. | Other | 1 |
| Diagnosis strategy and subsequent therapeutic reassessmentPerformed by geriatricians, following a decision tree, based on medical history, electrocardiogram, cardiac echotomography and stress scintigraphy | Other | 1 |
Primary outcome
therapeutical impact of a reassessment strategy in the diagnosis of coronary heart disease in elderly
Time frame: during hospitalization
1 secondary outcome
part link, in the treatment modification, with diagnosis reassessment and the part link with treatment optimization, death and rehospitalization in the subsequent 6 and 12 months
Time frame: during hospitalization
Results and safety
The study was stopped early (reason given: End of recruitment period). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
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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.
legrain sylvie principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diagnosis reassessment and Diagnosis strategy and subsequent therapeutic reassessment in people with Myocardial Ischemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 1 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: stopped early, as of the sponsor's last update on 8 Mar 2016. 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 France. 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 was stopped early (reason given: End of recruitment period). Results are not available in the source record.
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?
therapeutical impact of a reassessment strategy in the diagnosis of coronary heart disease in elderly (time frame: during hospitalization). It is what the study was designed to measure, not a finding.
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 8 Mar 2016.