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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02587481
Other study ID # 15-057
Secondary ID
Status Completed
Phase N/A
First received October 15, 2015
Last updated November 17, 2017
Start date November 2015
Est. completion date May 2017

Study information

Verified date November 2017
Source RWTH Aachen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this open, monocentric, observational study acute coronary syndrom (ACS) patients will be characterized by pneumological examination concerning a concomitant chronic obstructive pulmonary disease (COPD). Often COPD coexists with ACS; therefore ACS patients benefit either from prevention or potential therapy of chronic hypoxia.


Description:

In this study patients with either non ST-segment-elevation myocardial infarction (NSTEMI) or ST-segment-elevation myocardial infarction (STEMI) will be included. After amnesis patients will undergo blood withdrawal, blood-gas analysis and examinations concerning pulmonary function (Bodyplethysmography). In addition to routine blood withdrawal for differential blood count, 9 ml blood sample is takenfor molecular analysis of relevant prognostic chronic obstructive pulmonary disease (COPD)-blood based biomarkers, an for establishing a library of biomaterial in form of a biobank.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date May 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Written declaration of consent

- Patients with acute myocardial infarct which can be either non ST-segment-elevation myocardial infarct (NSTEMI) or ST-segment-elevation myocardial infarct (STEMI), in both cases exaggeration of cardiac ischaemic markers

Exclusion Criteria:

- Patients not fulfilling the incluson criterias or:

- Pregnant or breastfeeding women

- Participation in other studies

- Persons in depency from the sponsor or working with the sponsor

- Persons without mental ability or capacity to understand and follow the instructions of the investigator

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Amrei Pelzer Aachen NRW

Sponsors (1)

Lead Sponsor Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with Acute Coronary Syndrom (ACS) and concomitant Chronic Obstructive Pulmonary Disease (COPD) During 1-2 hours (at time of examination)
Secondary Molecular analysis of relevant blood based chronic obstructive pulmonary disease (COPD) biomarkers An average of 1 day
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