Acute Coronary SyndromPAPANCT02587481
Pneumological Acute Coronary Syndrom (ACS) Phenotyping Aachen
An observational study of Acute Coronary Syndrom and Chronic Obstructive Pulmonary Syndrom, run by RWTH Aachen University at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrom, Chronic Obstructive Pulmonary Syndrom
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2015to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with either non ST-segment-elevation myocardial infarction (NSTEMI) or ST-segment-elevation myocardial infarction (STEMI)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- Acute coronary syndrom, Chronic obstructive pulmonary disease, Myocardial infarction, Blood based biomarkers
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Acute Coronary Syndrom (ACS) and concomitant Chronic Obstructive Pulmonary Disease (COPD)
Measured: During 1-2 hours (at time of examination)
Secondary outcomes (1)
Molecular analysis of relevant blood based chronic obstructive pulmonary disease (COPD) biomarkers
Measured: An average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Dreher, Univ.-Prof. Dr. med., Principal investigator, RWTH Aachen University Hospital MK1VIncent Brandenburg, apl. Prof. Dr. med, Principal investigator, RWTH Aachen University Hospital MK1Christian Cornelissen, Dr. med, Principal investigator, RWTH Aachen University Hospital MK1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587481
- Sponsor's protocol ID
- 15-057
- Acronym
- PAPA
- Status last verified
- Nov 2017
- First submitted
- 15 Oct 2015
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pneumological Phenotyping of Acute Coronary Syndrom (ACS) Patients Concerning Concomitant Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT02587481
- Acronym / sponsor ID
- PAPA / 15-057
- Keywords
- Acute coronary syndrom, Chronic obstructive pulmonary disease, Myocardial infarction, Blood based biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with either non ST-segment-elevation myocardial infarction (NSTEMI) or ST-segment-elevation myocardial infarction (STEMI)
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
Molecular analysis of relevant blood based chronic obstructive pulmonary disease (COPD) biomarkers
Time frame: An average of 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Dreher, Univ.-Prof. Dr. med. principal investigator
RWTH Aachen University Hospital MK1
VIncent Brandenburg, apl. Prof. Dr. med principal investigator
RWTH Aachen University Hospital MK1
Christian Cornelissen, Dr. med principal investigator
RWTH Aachen University Hospital MK1
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrom and Chronic Obstructive Pulmonary Syndrom, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017.