Pneumological Acute Coronary Syndrom (ACS) Phenotyping Aachen (PAPA)

November 17, 2017 updated by: RWTH Aachen University

Pneumological Phenotyping of Acute Coronary Syndrom (ACS) Patients Concerning Concomitant Chronic Obstructive Pulmonary Disease (COPD)

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Aachen, NRW, Germany, 52074
        • Amrei Pelzer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with either non ST-segment-elevation myocardial infarction (NSTEMI) or ST-segment-elevation myocardial infarction (STEMI)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with Acute Coronary Syndrom (ACS) and concomitant Chronic Obstructive Pulmonary Disease (COPD)
Time Frame: During 1-2 hours (at time of examination)
During 1-2 hours (at time of examination)

Secondary Outcome Measures

Outcome Measure
Time Frame
Molecular analysis of relevant blood based chronic obstructive pulmonary disease (COPD) biomarkers
Time Frame: An average of 1 day
An average of 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Investigators

  • Principal Investigator: Michael Dreher, Univ.-Prof. Dr. med., RWTH Aachen University Hospital MK1
  • Principal Investigator: VIncent Brandenburg, apl. Prof. Dr. med, RWTH Aachen University Hospital MK1
  • Principal Investigator: Christian Cornelissen, Dr. med, RWTH Aachen University Hospital MK1

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

October 15, 2015

First Submitted That Met QC Criteria

October 23, 2015

First Posted (Estimate)

October 27, 2015

Study Record Updates

Last Update Posted (Actual)

November 20, 2017

Last Update Submitted That Met QC Criteria

November 17, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 15-057

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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