Coronary Artery DiseaseNCT00562679
Coronary Artery Disease and Sleep Apnea
An observational study of Coronary Artery Disease, run by Umeå University at 1 site in Sweden.
Trial summary
The purpose of this study is to determine the effect of sleep apnea on mortality, stroke and myocardial infarction among 408 patients with coronary artery disease referred for evaluation of coronary intervention who were examined with overnight cardio respiratory monitoring between March 1992 and June 1995. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 408 participants
- Where
- 1 siteSweden
- Study dates
- Mar 1992to Oct 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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patiens with coronary artery disease beeing referred for evaluation of coronary intervention
Who may be able to join
- Men and women younger than 70 with disabling angina pectoris and coronary disease according to coronary angiography.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Effects of Sleep Apnea in Patients With Coronary Artery Disease
The purpose of this study is to determine the effect of sleep apnea on mortality, stroke and myocardial infarction among 408 patients with coronary artery disease referred for evaluation of coronary intervention who were examined with overnight cardio respiratory monitoring between March 1992 and June 1995.
- Conditions
- Coronary Artery Disease
- Being tested
- There is no intervention
- Keywords
- Patients with coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no interventionOther
| Study group | Role | What they receive |
|---|---|---|
| 2 groups | The cohort is grouped according to one group with sleep apnea and one group without sleep apnea Receives: Other: There is no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke, death, acute myocardial infarction
Measured: 10 years from date of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2007 (estimated)
- Study startMar 1992
- Study completionOct 2007
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 Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Heart Lung Foundation, Norrländska Hjärtfonden, Jämtland County Council, Sweden
- Investigators
- Thomas Mooe, MD, PhD, Principal investigator, Dept Medicine, Östersund Hospital, Östersund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562679
- Sponsor's protocol ID
- 93-032
- Status last verified
- Jun 2008
- First submitted
- 21 Nov 2007
- Last updated
- 2 Jul 2008
- Results posted
- No
Publications
Valham F, Mooe T, Rabben T, Stenlund H, Wiklund U, Franklin KA. Increased risk of stroke in patients with coronary artery disease and sleep apnea: a 10-year follow-up. Circulation. 2008 Aug 26;118(9):955-60. doi: 10.1161/CIRCULATIONAHA.108.783290. Epub 2008 Aug 12.
PubMed 18697817
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Effects of Sleep Apnea in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00562679
- Acronym / sponsor ID
- 93-032
- Conditions
- Coronary Artery Disease
- Keywords
- Patients with coronary artery disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Swedish Heart Lung Foundation, Norrländska Hjärtfonden, Jämtland County Council, Sweden
- Study start
- Mar 1992
- Study completion
- Oct 2007 (actual)
- First posted
- 22 Nov 2007 (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.
The purpose of this study is to determine the effect of sleep apnea on mortality, stroke and myocardial infarction among 408 patients with coronary artery disease referred for evaluation of coronary intervention who were examined with overnight cardio respiratory monitoring between March 1992 and June 1995.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 groups | – | Other: There is no interventionThe cohort is grouped according to one group with sleep apnea and one group without sleep apnea |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patiens with coronary artery disease beeing referred for evaluation of coronary intervention
Key inclusion criteria (1 listed)
- Men and women younger than 70 with disabling angina pectoris and coronary disease according to coronary angiography.
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There is no intervention | Other | 2 groups |
Primary outcome
Stroke, death, acute myocardial infarction
Time frame: 10 years from date of inclusion
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 2 Jul 2008.
- Derived from this study: PubMed 18697817Valham F, Mooe T, Rabben T, Stenlund H, Wiklund U, Franklin KA. Increased risk of stroke in patients with coronary artery disease and sleep apnea: a 10-year follow-up. Circulation. 2008 Aug 26;118(9):955-60. doi: 10.1161/CIRCULATIONAHA.108.783290. Epub 2008 Aug 12.
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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.
Thomas Mooe, MD, PhD principal investigator
Dept Medicine, Östersund Hospital, Östersund
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 Coronary Artery Disease, run by Umeå University at 1 site in Sweden.
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 2 Jul 2008. 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 Sweden. 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?
Stroke, death, acute myocardial infarction (time frame: 10 years from date of inclusion). 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 NCT00562679, 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 2 Jul 2008.