Clinical trial NCT02587481: Pneumological Acute Coronary Syndrom (ACS) Phenotyping Aachen
Official title: Pneumological Phenotyping of Acute Coronary Syndrom (ACS) Patients Concerning Concomitant Chronic Obstructive Pulmonary Disease (COPD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrom
Chronic Obstructive Pulmonary Syndrom
Keywords: Acute coronary syndrom
Chronic obstructive pulmonary disease
Myocardial infarction
Blood based biomarkers
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with either non ST-segment-elevation myocardial infarction (NSTEMI) or ST-segment-elevation myocardial infarction (STEMI)

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with Acute Coronary Syndrom (ACS) and concomitant Chronic Obstructive Pulmonary Disease (COPD)
timeFrame: During 1-2 hours (at time of examination)
Secondary outcomes:
measure: Molecular analysis of relevant blood based chronic obstructive pulmonary disease (COPD) biomarkers
timeFrame: An average of 1 day
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Amrei Pelzer
state: NRW
Study officials:
affiliation: RWTH Aachen University Hospital MK1
name: Michael Dreher, Univ.-Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: RWTH Aachen University Hospital MK1
name: VIncent Brandenburg, apl. Prof. Dr. med
role: PRINCIPAL_INVESTIGATOR
affiliation: RWTH Aachen University Hospital MK1
name: Christian Cornelissen, Dr. med
role: PRINCIPAL_INVESTIGATOR
References: