NCT02740621

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

April 11, 2018

Status Verified

April 1, 2018

Enrollment Period

1 year

First QC Date

March 30, 2016

Last Update Submit

April 10, 2018

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

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

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hospitalized patients in University Hospital

You may qualify if:

  • years or older
  • written informed consent

You may not qualify if:

  • currently cancer
  • cognitive limitations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bergmannsheil department of pain therapy

Bochum, North Rhine-Westphalia, 44789, Germany

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof., Dr.

Study Record Dates

First Submitted

March 30, 2016

First Posted

April 15, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

August 1, 2017

Last Updated

April 11, 2018

Record last verified: 2018-04

Locations

DE(1)