Coronary Heart DiseaseMIOP/TRAPSNCT02740621
The Impact of Opioids in Coronary Heart Disease
An observational study of Coronary Heart Disease, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
In this study, the risk of opioid medications on coronary heart disease in adults is investigated. Patients with the necessity of a coronary angiography and control patients with a non-cardiac disease of the same hospital are inquired with a standardized questionnaire about demographic and clinical risk factors for… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Coronary Heart Disease
- How many people
- 750 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2016to Aug 2017
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hospitalized patients in University Hospital
Who may be able to join
- 40 years or older
- written informed consent
Who cannot join
- currently cancer
- cognitive limitations
Trial locations and contacts
1 site in 1 country.
Germany1 site
Bergmannsheil department of pain therapy
Bochum, North Rhine-Westphalia, 44789
About this study
Official title: Evaluation of Past Medications in Patients With Coronary Heart Disease and Patients Hospitalized for a Non-cardiac Reason
In this study, the risk of opioid medications on coronary heart disease in adults is investigated. Patients with the necessity of a coronary angiography and control patients with a non-cardiac disease of the same hospital are inquired with a standardized questionnaire about demographic and clinical risk factors for heart attack. An impact of opioid medications on coronary heart disease is hypothesised (MIOP).
In addition, all patients with coronary angiography should be consulted twice (after 3 and 6 months) to find out how many of these patients have developed a refractory angina pectoris (TRAPS).
- Conditions
- Coronary Heart Disease
- Medical subject headings
- Coronary Disease
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 with coronary heart disease | coronary angiography with finding coronary heart disease currently no cancer 40 years or older | |
| control patients | coronary angiography with exclusion coronary heart disease or other patients with non-cardiac diseases currently no cancer 40 years or older |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with opioid treatment (WHO II/ WHO III) within the last 10 years before present hospitalization, Interview with standardized CRF
Standardized assessment of opioid medications taken before hospital admission to evaluate the impact of opioids in coronary heart disease.
Exact doses, substances and intake habits are inquired.
Measured: 20 minutes
Number of patients with refractory angina pectoris, Interview with standardized CRF
Standardized assessment of angina pectoris symptoms and treatments to evaluate a refractory angina pectoris.
Changes of their medications are inquired twice.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Collaborators
- Mundipharma Research GmbH & Co KG
- Responsible party
- Principal investigator, Christoph Maier, Prof. Dr., Ruhr University of Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740621
- Sponsor's protocol ID
- MIOP
- Acronym
- MIOP/TRAPS
- Status last verified
- Apr 2018
- First submitted
- 30 Mar 2016
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Past Medications in Patients With Coronary Heart Disease and Patients Hospitalized for a Non-cardiac Reason
- ClinicalTrials.gov ID
- NCT02740621
- Acronym / sponsor ID
- MIOP/TRAPS / MIOP
- Conditions
- Coronary Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Collaborators
- Mundipharma Research GmbH & Co KG
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 15 Apr 2016 (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.
In this study, the risk of opioid medications on coronary heart disease in adults is investigated. Patients with the necessity of a coronary angiography and control patients with a non-cardiac disease of the same hospital are inquired with a standardized questionnaire about demographic and clinical risk factors for heart attack. An impact of opioid medications on coronary heart disease is hypothesised (MIOP).
In addition, all patients with coronary angiography should be consulted twice (after 3 and 6 months) to find out how many of these patients have developed a refractory angina pectoris (TRAPS).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with coronary heart disease | – | –coronary angiography with finding coronary heart disease currently no cancer 40 years or older |
| control patients | – | –coronary angiography with exclusion coronary heart disease or other patients with non-cardiac diseases currently no cancer 40 years or older |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hospitalized patients in University Hospital
Key inclusion criteria (2 listed)
- 40 years or older
- written informed consent
Key exclusion criteria (2 listed)
- currently cancer
- cognitive limitations
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
Number of patients with opioid treatment (WHO II/ WHO III) within the last 10 years before present hospitalization, Interview with standardized CRF
Time frame: 20 minutes
Standardized assessment of opioid medications taken before hospital admission to evaluate the impact of opioids in coronary heart disease. Exact doses, substances and intake habits are inquired.
Number of patients with refractory angina pectoris, Interview with standardized CRF
Time frame: 30 minutes
Standardized assessment of angina pectoris symptoms and treatments to evaluate a refractory angina pectoris. Changes of their medications are inquired twice.
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 2018.
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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.
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 Coronary Heart Disease, run by Ruhr University of Bochum at 1 site in Germany.
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 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 11 Apr 2018. 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 Germany. 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?
Number of patients with opioid treatment (WHO II/ WHO III) within the last 10 years before present hospitalization, Interview with standardized CRF (time frame: 20 minutes). The study lists 2 primary outcomes in all. 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 11 Apr 2018.