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NCT02740621 Clinical Trial

The Impact of Opioids in Coronary Heart Disease

Coronary Heart Disease Clinical Trial

— MIOP/TRAPS  

Official title:
Evaluation of Past Medications in Patients With Coronary Heart Disease and Patients Hospitalized for a Non-cardiac Reason

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02740621
Other study ID # MIOP
Secondary ID
Status Completed
Phase
First received March 30, 2016
Last updated April 10, 2018
Start date January 2016
Est. completion date August 2017

Study information
Verified date April 2018
Source Ruhr University of Bochum
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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).

Recruitment information / eligibility
Status Completed
Enrollment 750
Est. completion date August 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria:

- 40 years or older

- written informed consent

Exclusion Criteria:

- currently cancer

- cognitive limitations

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Bergmannsheil department of pain therapy Bochum Nordrhein-Westfalen

Sponsors (2)
Lead Sponsor Collaborator
Ruhr University of Bochum Mundipharma Research GmbH & Co KG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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.		 20 minutes
Primary 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.		 30 minutes
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