Cardiac Assessment and Takotsubo-stunning Among COPD-exacerbations In-Hospital
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSahlgrenska University Hospital
About this trial
The goal of this prospective observational study is to investigate to what extent acute exacerbation of chronic obstructive pulmonary disease (AE-COPD) triggers Takotsubo-stunning, and how this affects the outcome for these patients.
The main questions it aims to answer are:
1. What is cumulative incidence of Takotsubo-stunning in patients hospitalized for AE-COPD at Sahlgrenska University Hospital/S (Gothenburg, Sweden)? 2. Among patients hospitalized for AE-COPD at Sahlgrenska University Hospital/S, what is the risk of in-hospital clinical manifestations of acute heart failure in patients with Takotsubo-stunning compared to those without?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (≥ 18 years old) admitted to hospital ward for AE-COPD
Inclusion within 72 hours of admission,
Written informed consent
Disqualifiers
Prior acute myocardial infarction or known pre-existing persistent regional wall motion abnormality or left ventricular dysfunction (left ventricular ejection fraction [LVEF] <50%)
Expected inability to comply with the protocol (e.g. dementia)
Trial population
Adult patients admitted to hospital ward for AE-COPD within 72 hours
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Reversible left ventricular dysfunction (myocardial stunning) according to echocardiography
Echocardiographic signs of myocardial stunning/Takotsubo-stunning at inclusion (day 0) with recovery of left ventricular function at day 1 and/or day 30
Time frame
30 days2
Clinical signs of acute heart failure at inclusion (day 0) or day 1 according to the Killip Classification
Acute heart failure will be defined as modified Killip Class \>1, and will be compared between patients with vs without myocardial stunning/Takotsubo-stunning
Time frame
2 daysSecondary outcomes
1
In-hospital Major Adverse Cardiac Events (MACE)
Defined as nonfatal myocardial infarction, nonfatal stroke or cardiovascular death; at some point during hospitalization. Comparison between patients with versus without myocardial stunning/Takotsubo-stunning.
Time frame
At discharge from hospital (on average 5 days)2
Admission to intensive care unit (ICU) during index hospitalization
Admission to ICU at any point during hospitalization. Comparison between patients with versus without myocardial stunning/Takotsubo-stunning.
Time frame
At discharge from hospital (on average 5 days)3
In-hospital death and death within one year
In-hospital death and death within one year. Comparison between patients with versus without myocardial stunning/Takotsubo-stunning.
Time frame
At time of in-hospital death or at discharge from hospital (on average 5 days) and after 1 yearSponsors and contacts
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Source ClinicalTrials.gov