NCT02587481

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2015

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

First Submitted

Initial submission to the registry

October 15, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

November 20, 2017

Status Verified

November 1, 2017

Enrollment Period

1.5 years

First QC Date

October 15, 2015

Last Update Submit

November 17, 2017

Conditions

Acute Coronary SyndromChronic Obstructive Pulmonary Syndrom

Keywords

Acute coronary syndromChronic obstructive pulmonary diseaseMyocardial infarctionBlood based biomarkers

Outcome Measures

Primary Outcomes (1)

  • Number of patients with Acute Coronary Syndrom (ACS) and concomitant Chronic Obstructive Pulmonary Disease (COPD)

    During 1-2 hours (at time of examination)

Secondary Outcomes (1)

  • Molecular analysis of relevant blood based chronic obstructive pulmonary disease (COPD) biomarkers

    An average of 1 day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amrei Pelzer

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, Blood plasm

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMyocardial Infarction

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaNecrosis

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2015

First Posted

October 27, 2015

Study Start

November 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

November 20, 2017

Record last verified: 2017-11

Locations

DE(1)