Cardiovascular DiseaseOCTOCARDIONCT01121679
French Observatory on Hospitalizations in Cardiology of Patients of 80 Years and Over
An observational study of Cardiovascular Disease, run by French Cardiology Society at 1 site in France.
Trial summary
Because of increased life expectancy and improved therapeutic methods in cardiology, the proportion of very old patients with cardiovascular disease increases. However, clinical practice "in real life" are still insufficiently known in this population. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Cardiovascular Disease
- How many people
- 534 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2009to Jun 2010
- 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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged 80 years and older and hospitalized in a cardiology department which participate in this study.
Who may be able to join
- Patient aged 80 years or more
- Patient present in a cardiology service in the morning (8:00 to 12:00) the day of the survey
- Admission to the service took place on the survey day or in the 15 days preceding the survey.
Who cannot join
- Patient with age <80 years.
- Patient who have expressed a refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Because of increased life expectancy and improved therapeutic methods in cardiology, the proportion of very old patients with cardiovascular disease increases. However, clinical practice "in real life" are still insufficiently known in this population. The recommendations still lack of studies specifically devoted to elderly or very elderly, an extrapolation of data based on evidence obtained in younger populations.
This is a multicenter observational study during a day. On this day, all participating centers fill a questionnaire for each patient 80 years or older hospitalized in their service.
Read the detailed description
Information about the center will be collected: non-university or university center, presence of coronary angiography room, number of beds, number of patients 80 years or older hospitalized in the day of the investigation.
The questionnaire is designed to:
- Know the history of cardiovascular and noncardiovascular patient and degree of dependence
- Know the reason for hospitalization
- Evaluate the diagnostic and therapeutic already implemented or planned for this patient
The day of the survey, information on each patient 80 years or older hospitalized in the service will be collected:
- Patient Data: date of birth, sex, status. The patient identification data (name, surname, address) will not be collected.
- Patient History: date of last hospitalization, life, cardiovascular risk factors, cardiovascular and non cardiovascular history, date of last hospitalization, life
- Circumstances of admission: course of care before admission, admission to intensive care unit or hospital unit classical primary diagnosis and diagnosis (s) partner (s)
- Initial assessment: treatment admission, major hemodynamic, electrocardiographic and biological
- Regarding the current hospitalization: diagnosis already implemented or planned (echocardiography, angiography, electrophysiological study, etc ...), therapeutic methods already implemented or planned angioplasty, percutaneous valve intervention, conventional or biventricular stimulation, cardiac surgery, medication
- Become of the patient after hospitalization
- The clinician's subjective impressions about the condition of the patient and monitoring recommendations
- Assessment of addiction: ADL Scale
No monitoring of patients is contemplated.
- Conditions
- Cardiovascular Disease
- Keywords
- Older patients, Aged, 80 and Over, Cardiology
- Medical subject headings
- 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 |
|---|---|---|
| Patients aged 80 years and older | Patients aged 80 years and older and hospitalized in a cardiology department |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients for which national guidelines were followed
Evaluate clinical practice and particularly the monitoring of recommendations of international scientific societies in the population of very elderly (≥ 80 years)
Measured: 1 day
Secondary outcomes (1)
Percentage of patients aged 80 and older hospitalized in the university and non university
Better understand the demographics of cardiology services in France (Demography)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startOct 2009
- Primary completionOct 2009
- Study completionJun 2010
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 Cardiovascular 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 534 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moubarak Ghassan, French Cardiology Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121679
- Sponsor's protocol ID
- 09472
- Acronym
- OCTOCARDIO
- Status last verified
- Aug 2019
- First submitted
- 16 Apr 2010
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moubarak G, Ernande L, Godin M, Cazeau S, Vicaut E, Hanon O, Zuily S, Tournoux F, Danchin N, Derumeaux G, Mechulan A. Impact of comorbidity on medication use in elderly patients with cardiovascular diseases: the OCTOCARDIO study. Eur J Prev Cardiol. 2013 Aug;20(4):524-30. doi: 10.1177/2047487312444235. Epub 2012 Mar 23.
PubMed 22447578
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Observatory on Hospitalizations in Cardiology of Patients of 80 Years and Over
- ClinicalTrials.gov ID
- NCT01121679
- Acronym / sponsor ID
- OCTOCARDIO / 09472
- Conditions
- Cardiovascular Disease
- Keywords
- Older patients, Aged, 80 and Over, Cardiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 534 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Study start
- Oct 2009 (actual)
- Primary completion
- Oct 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 12 May 2010 (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.
Because of increased life expectancy and improved therapeutic methods in cardiology, the proportion of very old patients with cardiovascular disease increases. However, clinical practice "in real life" are still insufficiently known in this population. The recommendations still lack of studies specifically devoted to elderly or very elderly, an extrapolation of data based on evidence obtained in younger populations.
This is a multicenter observational study during a day. On this day, all participating centers fill a questionnaire for each patient 80 years or older hospitalized in their service.
Detailed description
Information about the center will be collected: non-university or university center, presence of coronary angiography room, number of beds, number of patients 80 years or older hospitalized in the day of the investigation.
The questionnaire is designed to:
- Know the history of cardiovascular and noncardiovascular patient and degree of dependence
- Know the reason for hospitalization
- Evaluate the diagnostic and therapeutic already implemented or planned for this patient
The day of the survey, information on each patient 80 years or older hospitalized in the service will be collected:
- Patient Data: date of birth, sex, status. The patient identification data (name, surname, address) will not be collected.
- Patient History: date of last hospitalization, life, cardiovascular risk factors, cardiovascular and non cardiovascular history, date of last hospitalization, life
- Circumstances of admission: course of care before admission, admission to intensive care unit or hospital unit classical primary diagnosis and diagnosis (s) partner (s)
- Initial assessment: treatment admission, major hemodynamic, electrocardiographic and biological
- Regarding the current hospitalization: diagnosis already implemented or planned (echocardiography, angiography, electrophysiological study, etc ...), therapeutic methods already implemented or planned angioplasty, percutaneous valve intervention, conventional or biventricular stimulation, cardiac surgery, medication
- Become of the patient after hospitalization
- The clinician's subjective impressions about the condition of the patient and monitoring recommendations
- Assessment of addiction: ADL Scale
No monitoring of patients is contemplated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients aged 80 years and older | – | –Patients aged 80 years and older and hospitalized in a cardiology department |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 80 years and older and hospitalized in a cardiology department which participate in this study.
Key inclusion criteria (3 listed)
- Patient aged 80 years or more
- Patient present in a cardiology service in the morning (8:00 to 12:00) the day of the survey
- Admission to the service took place on the survey day or in the 15 days preceding the survey.
Key exclusion criteria (2 listed)
- Patient with age <80 years.
- Patient who have expressed a refusal to participate in the study
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
Percentage of patients for which national guidelines were followed
Time frame: 1 day
Evaluate clinical practice and particularly the monitoring of recommendations of international scientific societies in the population of very elderly (≥ 80 years)
1 secondary outcome
Percentage of patients aged 80 and older hospitalized in the university and non university
Time frame: 1 day
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 7 Aug 2019.
- Results publication: PubMed 22447578Moubarak G, Ernande L, Godin M, Cazeau S, Vicaut E, Hanon O, Zuily S, Tournoux F, Danchin N, Derumeaux G, Mechulan A. Impact of comorbidity on medication use in elderly patients with cardiovascular diseases: the OCTOCARDIO study. Eur J Prev Cardiol. 2013 Aug;20(4):524-30. doi: 10.1177/2047487312444235. Epub 2012 Mar 23.
Related trials for Cardiovascular Disease
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cardiovascular Disease, run by French Cardiology Society 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 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: finished, as of the sponsor's last update on 7 Aug 2019. 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 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.
What does the primary outcome measure?
Percentage of patients for which national guidelines were followed (time frame: 1 day). 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 NCT01121679, 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 7 Aug 2019.