Myocardial IschemiaNCT00382421
Study to Investigate Effects of Antiischemic Drug Therapy in Silent Ischemia
A study testing bisoprolol, amlodipine and molsidomine in people with Myocardial Ischemia, run by Luzerner Kantonsspital at 1 site in Switzerland.
Trial summary
There is a lack of data on the prognostic importance of silent ischemia in totally asymptomatic subjects without history of coronary artery disease (CAD), and, particularly, on a possible benefit of medical therapy in such patients. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- bisoprolol, amlodipine and molsidomine
- How many people
- Not given
- Where
- 1 siteSwitzerland
- Study dates
- Feb 1992to Apr 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented silent myocardial ischemia type I
- At least one cardiovascular risk factor
Who cannot join
- History of cardiovascular disease
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Cardiology, Hospital Lucerne
Lucerne, Canton of Lucerne, 6000
About this study
Official title: Swiss Interventional Study on Silent Ischemia (SWISSI 1)
There is a lack of data on the prognostic importance of silent ischemia in totally asymptomatic subjects without history of coronary artery disease (CAD), and, particularly, on a possible benefit of medical therapy in such patients. SWISSI 1 therefore recruits totally asymptomatic subjects older than 40 years of age without any history of CAD but one cardiovascular risk factor with documented silent ischemia. Participants are randomized to open antianginal drug therapy and risk factor control versus only risk factor management and followed up for ≥ 10 years.
Read the detailed description
Although there is still controversy regarding why ischemic episodes are symptomatic in some patients and completely asymptomatic in others, it is now widely accepted that silent ischemia, like symptomatic episodes, negatively affects prognosis. Silent ischemia may occur in totally asymptomatic patients without (type I) or with a history (type II) of an ischemic cardiac event and coexists with symptomatic episodes in many patients (type III). However, there is a lack of data on the prognostic importance of silent ischemia in totally asymptomatic subjects without history of coronary artery disease (CAD), i.e. silent ischemia type I, and, particularly, on a possible benefit of medical therapy in such patients. Reasons lie in the difficulty to identify such patients and their expected low event rates implying that large patient populations and/or long follow-up periods would be necessary to come to definite conclusions. Still, to address this problem, we perform SWISSI 1 which includes totally asymptomatic subjects older than 40 years of age without any history of CAD but one cardiovascular risk factor with documented silent ischemia. They are randomized to open antianginal drug therapy and risk factor control versus only risk factor management and followed up for ≥ 10 years.
- Conditions
- Myocardial Ischemia
- Being tested
- bisoprolol, amlodipine, molsidomine, acetylsalicylic acid
- Keywords
- Myocardial Ischemia, Randomized Controlled Trials, Drug Therapy
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bisoprololDrug
amlodipineDrug
molsidomineDrug
acetylsalicylic acidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Combination of cardiac death, non-fatal myocardial infarction, unstable angina pectoris, and revascularization
Secondary outcomes (5)
Overall mortality
Cardiac death
Non-fatal myocardial infarction
Stable and unstable angina pectoris
Revascularization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2006 (estimated)
- Study startFeb 1992
- Study completionApr 2006
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 Myocardial IschemiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Investigators
- Paul Erne, MD, Principal investigator, Department of Cardiology, Hospital LucernePaul Erne, MD, Study chair, Department of Cardiology, Hospital Lucerne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382421
- Sponsor's protocol ID
- 1
- Status last verified
- Oct 2006
- First submitted
- 28 Sep 2006
- Last updated
- 12 Oct 2006
- Results posted
- No
Publications
Schoenenberger AW, Jamshidi P, Zuber M, Stuck AE, Pfisterer M, Erne P. Coronary artery disease is common in asymptomatic patients with signs of myocardial ischemia. Eur J Intern Med. 2009 Oct;20(6):607-10. doi: 10.1016/j.ejim.2009.04.001. Epub 2009 May 8.
PubMed 19782922
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swiss Interventional Study on Silent Ischemia (SWISSI 1)
- ClinicalTrials.gov ID
- NCT00382421
- Acronym / sponsor ID
- 1
- Conditions
- Myocardial Ischemia
- Keywords
- Myocardial Ischemia, Randomized Controlled Trials, Drug Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Study start
- Feb 1992
- Study completion
- Apr 2006
- First posted
- 29 Sep 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 a lack of data on the prognostic importance of silent ischemia in totally asymptomatic subjects without history of coronary artery disease (CAD), and, particularly, on a possible benefit of medical therapy in such patients. SWISSI 1 therefore recruits totally asymptomatic subjects older than 40 years of age without any history of CAD but one cardiovascular risk factor with documented silent ischemia. Participants are randomized to open antianginal drug therapy and risk factor control versus only risk factor management and followed up for ≥ 10 years.
Detailed description
Although there is still controversy regarding why ischemic episodes are symptomatic in some patients and completely asymptomatic in others, it is now widely accepted that silent ischemia, like symptomatic episodes, negatively affects prognosis. Silent ischemia may occur in totally asymptomatic patients without (type I) or with a history (type II) of an ischemic cardiac event and coexists with symptomatic episodes in many patients (type III). However, there is a lack of data on the prognostic importance of silent ischemia in totally asymptomatic subjects without history of coronary artery disease (CAD), i.e. silent ischemia type I, and, particularly, on a possible benefit of medical therapy in such patients. Reasons lie in the difficulty to identify such patients and their expected low event rates implying that large patient populations and/or long follow-up periods would be necessary to come to definite conclusions. Still, to address this problem, we perform SWISSI 1 which includes totally asymptomatic subjects older than 40 years of age without any history of CAD but one cardiovascular risk factor with documented silent ischemia. They are randomized to open antianginal drug therapy and risk factor control versus only risk factor management and followed up for ≥ 10 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Documented silent myocardial ischemia type I
- At least one cardiovascular risk factor
Key exclusion criteria (1 listed)
- History of cardiovascular disease
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 |
|---|---|---|
| bisoprolol | Drug | – |
| amlodipine | Drug | – |
| molsidomine | Drug | – |
| acetylsalicylic acid | Drug | – |
Primary outcome
Combination of cardiac death, non-fatal myocardial infarction, unstable angina pectoris, and revascularization
5 secondary outcomes
Overall mortality
Cardiac death
Non-fatal myocardial infarction
Stable and unstable angina pectoris
Revascularization
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 12 Oct 2006.
- Derived from this study: PubMed 19782922Schoenenberger AW, Jamshidi P, Zuber M, Stuck AE, Pfisterer M, Erne P. Coronary artery disease is common in asymptomatic patients with signs of myocardial ischemia. Eur J Intern Med. 2009 Oct;20(6):607-10. doi: 10.1016/j.ejim.2009.04.001. Epub 2009 May 8.
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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.
Paul Erne, MD principal investigator
Department of Cardiology, Hospital Lucerne
Paul Erne, MD study chair
Department of Cardiology, Hospital Lucerne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bisoprolol, amlodipine and molsidomine in people with Myocardial Ischemia, run by Luzerner Kantonsspital at 1 site in Switzerland.
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 2 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: finished, as of the sponsor's last update on 12 Oct 2006. 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 Switzerland. 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?
Combination of cardiac death, non-fatal myocardial infarction, unstable angina pectoris, and revascularization. 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 NCT00382421, 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 12 Oct 2006.