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The Impact of Opioids in Coronary Heart Disease (MIOP/TRAPS)

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ClinicalTrials.gov Identifier: NCT02740621
Recruitment Status : Completed
First Posted : April 15, 2016
Last Update Posted : April 11, 2018
Sponsor:
Collaborator:
Mundipharma Research GmbH & Co KG
Information provided by (Responsible Party):
Christoph Maier, Prof. Dr., Ruhr University of Bochum

Brief 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 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).


Condition or disease
Coronary Heart Disease

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Study Type : Observational
Actual Enrollment : 750 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Past Medications in Patients With Coronary Heart Disease and Patients Hospitalized for a Non-cardiac Reason
Actual Study Start Date : January 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. 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.


  2. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
hospitalized patients in University Hospital
Criteria

Inclusion Criteria:

  • 40 years or older
  • written informed consent

Exclusion Criteria:

  • currently cancer
  • cognitive limitations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02740621


Locations
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Germany
Bergmannsheil department of pain therapy
Bochum, Nordrhein-Westfalen, Germany, 44789
Sponsors and Collaborators
Ruhr University of Bochum
Mundipharma Research GmbH & Co KG

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Responsible Party: Christoph Maier, Prof. Dr., Prof., Dr., Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT02740621    
Other Study ID Numbers: MIOP
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases