Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597331
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
Catching and Assessing Takotsubo-stunning Among COPD-exacerbations In-Hospital
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Observational Study of Myocardial Stunning in Patients Hospitalized for Exacerbation of Chronic Obstructive Pulmonary Disease
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CATCH
Brief Summary:
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 HospitalS Gothenburg Sweden
2 Among patients hospitalized for AE-COPD at Sahlgrenska University HospitalS what is the risk of in-hospital clinical manifestations of acute heart failure in patients with Takotsubo-stunning compared to those without
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 HospitalS Gothenburg Sweden
2 Among patients hospitalized for AE-COPD at Sahlgrenska University HospitalS what is the risk of in-hospital clinical manifestations of acute heart failure in patients with Takotsubo-stunning compared to those without
Detailed Description:
PURPOSE
The purpose of Catching and Assessing Takotsubo-stunning among COPD-exacerbations in-Hospital CATCH is to investigate to what extent AE-COPD triggers Takotsubo-stunning in patients admitted to in-hospital care and how this affects the outcome for these patients
BACKGROUND
Acute exacerbation of chronic obstructive pulmonary disease AE-COPD may cause acute heart failure due to stress-induced myocardial stunning which is probably underdiagnosed or undiagnosed in clinical routine Elements of myocardial stunning is associated with several conditions however the Takotsubo syndrome TS is probably a pure form of myocardial stunning Therefore the term Takotsubo-stunning is sometimes used to describe the myocardial stunning that occur in TS
TS is an acute heart failure syndrome associated with emotional or physical stress predominately affecting females 90 females in the postmenopausal ages TS is characterized by rapid onset of regional wall motion abnormality typically widespread apical akinesia and reversible left ventricular dysfunction One of the most widely reported physical triggers of TS is AE-COPD and COPD is overrepresented among patients with TS Concurrent respiratory disease such as AE-COPD complicate the diagnosis of TS since the cardiac condition may be masked by pulmonary symptoms and the respiratory symptoms may be further exacerbated by Takotsubo-stunning Also a cornerstone in the treatment for AE-COPD is high doses of beta-2-adrenergic agonists through inhalation This may be unfavourable and possibly detrimental for a patient with Takotsubo-stunning since adrenergic overstimulation in general and overstimulation of cardiac beta-2-adrenergic receptor in particular seems to be involved in the pathophysiology of TS
Although it is known that AE-COPD is common among patients with TS research is lacking regarding the inverse relationship ie how common TS is among patients with AE-COPD Therefore the investigators aim to elucidate to what extent AE-COPD triggers Takotsubo-stunning through investigating the incidence of Takotsubo-stunning in AE-COPD
HYPOTHESES
1 Among adult patients admitted for in-hospital care for AE-COPD at Sahlgrenska University HospitalS Gothenburg Sweden a non-negligible proportion more than one out of ten develop Takotsubo-stunning as complication triggered by the AE-COPD
2 Within in the above-mentioned patient group AE-COPD complicated by Takotsubo-stunning is associated with more clinical signs of acute heart failure and a worse outcome longer length of stay more complications higher mortality compared to AE-COPD not complicated by TS
STUDY DESIGN
CATCH is a prospective observational cohort study originating from the section for Acute and Cardiovascular Medicine at the department of Emergency Medicine and Geriatrics at Sahlgrenska University HospitalS SUS Patients admitted to SUS hospital wards 90 or 91 acute internal medicine 19 or 32 pulmonary medicine and general internal medicine 16 or 29 endocrinology and gastroenterology for AE-COPD are eligible for inclusion
To identify possible Takotsubo-stunning included patients will be screened for echocardiographic signs of regional wall motion abnormality andor left ventricular dysfunction where positive and negative screening will be defined as follows
POSITIVE Presence of any regional wall motion abnormality andor left ventricular dysfunction LVEF 50
NEGATIVE Absence of regional wall motion abnormality and no left ventricular dysfunction LVEF 50
If negative screening will be repeated once after 24 -6 hours If positive ie screening reveals signs of regional wall motion abnormality andor cardiac dysfunction screening will be converted to a full echocardiographic examination according to standard clinical protocol which will be repeated after 24 -6 hours and after 30 -48 hours days Reversibility will be defined as improvement in cardiac function between first positive echocardiographic examination and day 30 Such transient cardiac dysfunction will be regarded as Takotsubo-stunning provided no other cause has been identified as per diagnostic criteria for TS Persistent cardiac dysfunction is a pre-defined exclusion-criteria and therefore these patients will be excluded from the analysis Patients who turn out positive in screening will be offered inclusion in STAMI-study Stunning in Takotsubo versus Acute Myocardial Infarction clinical trials identifier NCT04448639 ongoing since 2020
OTHER PROCEDURES AND COLLECTION OF DATA
All patients will be interviewed according to a questionnaire regarding presenting symptoms Blood sampling for analysis of NTproBNP ECG and chest x-ray will be performed at inclusion day 0 and day 1 Baseline characteristics will be collected from the patients medical charts and vital parameters will be registered the first three days In-hospital complicationsdeath will be registered consecutively COPD GOLD Global initiative for Obstructive Lung Disease gradegroup and severity of exacerbation will be registered In follow-up data from re-evaluation of COPD clinical routine after hospital care for AE-COPD will be collected Spirometry diffusion capacity static lung volumes 6-min walk test COPD assessment test
PRIMARY ENDPOINTS
1 1-year cumulative incidence of Takotsubo-stunning
2 Clinical signs of acute heart failure during hospitalization defined as modified Killip Class 1 explained below
Modified Killip Class To assess clinical signs heart failure the investigators will use a modified version of Killip Classification of acute heart failure originally developed for assessing acute heart failure after myocardial infarction Killip class I-III will be assessed using pulmonary ultrasound instead of auscultation sounds Killip Class IV cardiogenic shock will be assessed unmodified according to clinical routine
SECONDARY ENDPOINTS
1 In-hospital Major Adverse Cardiac Events MACE nonfatal myocardial infarction nonfatal stroke or cardiovascular death
2 Admission to intensive care unit
3 In-hospital death and death within one year
SCIENTIFIC IMPORTANCE
A link seems to exist between AE-COPD and myocardial stunningTS This is important for two main reasons
1 The cardiac condition may be masked by the respiratory symptoms and the clinical signs of AE-COPD leading to delayed or missed diagnosis of the cardiac component
2 Myocardial stunning with cardiac dysfunction may further exacerbate the patients condition leading to prolonged time to recovery due to concomitant untreated AHF and an increased risk of severe cardiac complications
Another important aspect is the treatment for AE-COPD which may include treatment with high doses of beta-2-agonists Catecholamines are part of the pathophysiological cause of myocardial stunning and catecholaminergic drugs may further aggravate myocardial stunning In fact beta-2-agonists specifically has been shown to likely trigger myocardial stunningTS Therefore the routine treatment for AE-COPD may be associated with a risk of harming patients with concomitant AE-COPD and myocardial stunning If successful the CATCH-study may improve the quality of care and outcome for patients with AE-COPD
The purpose of Catching and Assessing Takotsubo-stunning among COPD-exacerbations in-Hospital CATCH is to investigate to what extent AE-COPD triggers Takotsubo-stunning in patients admitted to in-hospital care and how this affects the outcome for these patients
BACKGROUND
Acute exacerbation of chronic obstructive pulmonary disease AE-COPD may cause acute heart failure due to stress-induced myocardial stunning which is probably underdiagnosed or undiagnosed in clinical routine Elements of myocardial stunning is associated with several conditions however the Takotsubo syndrome TS is probably a pure form of myocardial stunning Therefore the term Takotsubo-stunning is sometimes used to describe the myocardial stunning that occur in TS
TS is an acute heart failure syndrome associated with emotional or physical stress predominately affecting females 90 females in the postmenopausal ages TS is characterized by rapid onset of regional wall motion abnormality typically widespread apical akinesia and reversible left ventricular dysfunction One of the most widely reported physical triggers of TS is AE-COPD and COPD is overrepresented among patients with TS Concurrent respiratory disease such as AE-COPD complicate the diagnosis of TS since the cardiac condition may be masked by pulmonary symptoms and the respiratory symptoms may be further exacerbated by Takotsubo-stunning Also a cornerstone in the treatment for AE-COPD is high doses of beta-2-adrenergic agonists through inhalation This may be unfavourable and possibly detrimental for a patient with Takotsubo-stunning since adrenergic overstimulation in general and overstimulation of cardiac beta-2-adrenergic receptor in particular seems to be involved in the pathophysiology of TS
Although it is known that AE-COPD is common among patients with TS research is lacking regarding the inverse relationship ie how common TS is among patients with AE-COPD Therefore the investigators aim to elucidate to what extent AE-COPD triggers Takotsubo-stunning through investigating the incidence of Takotsubo-stunning in AE-COPD
HYPOTHESES
1 Among adult patients admitted for in-hospital care for AE-COPD at Sahlgrenska University HospitalS Gothenburg Sweden a non-negligible proportion more than one out of ten develop Takotsubo-stunning as complication triggered by the AE-COPD
2 Within in the above-mentioned patient group AE-COPD complicated by Takotsubo-stunning is associated with more clinical signs of acute heart failure and a worse outcome longer length of stay more complications higher mortality compared to AE-COPD not complicated by TS
STUDY DESIGN
CATCH is a prospective observational cohort study originating from the section for Acute and Cardiovascular Medicine at the department of Emergency Medicine and Geriatrics at Sahlgrenska University HospitalS SUS Patients admitted to SUS hospital wards 90 or 91 acute internal medicine 19 or 32 pulmonary medicine and general internal medicine 16 or 29 endocrinology and gastroenterology for AE-COPD are eligible for inclusion
To identify possible Takotsubo-stunning included patients will be screened for echocardiographic signs of regional wall motion abnormality andor left ventricular dysfunction where positive and negative screening will be defined as follows
POSITIVE Presence of any regional wall motion abnormality andor left ventricular dysfunction LVEF 50
NEGATIVE Absence of regional wall motion abnormality and no left ventricular dysfunction LVEF 50
If negative screening will be repeated once after 24 -6 hours If positive ie screening reveals signs of regional wall motion abnormality andor cardiac dysfunction screening will be converted to a full echocardiographic examination according to standard clinical protocol which will be repeated after 24 -6 hours and after 30 -48 hours days Reversibility will be defined as improvement in cardiac function between first positive echocardiographic examination and day 30 Such transient cardiac dysfunction will be regarded as Takotsubo-stunning provided no other cause has been identified as per diagnostic criteria for TS Persistent cardiac dysfunction is a pre-defined exclusion-criteria and therefore these patients will be excluded from the analysis Patients who turn out positive in screening will be offered inclusion in STAMI-study Stunning in Takotsubo versus Acute Myocardial Infarction clinical trials identifier NCT04448639 ongoing since 2020
OTHER PROCEDURES AND COLLECTION OF DATA
All patients will be interviewed according to a questionnaire regarding presenting symptoms Blood sampling for analysis of NTproBNP ECG and chest x-ray will be performed at inclusion day 0 and day 1 Baseline characteristics will be collected from the patients medical charts and vital parameters will be registered the first three days In-hospital complicationsdeath will be registered consecutively COPD GOLD Global initiative for Obstructive Lung Disease gradegroup and severity of exacerbation will be registered In follow-up data from re-evaluation of COPD clinical routine after hospital care for AE-COPD will be collected Spirometry diffusion capacity static lung volumes 6-min walk test COPD assessment test
PRIMARY ENDPOINTS
1 1-year cumulative incidence of Takotsubo-stunning
2 Clinical signs of acute heart failure during hospitalization defined as modified Killip Class 1 explained below
Modified Killip Class To assess clinical signs heart failure the investigators will use a modified version of Killip Classification of acute heart failure originally developed for assessing acute heart failure after myocardial infarction Killip class I-III will be assessed using pulmonary ultrasound instead of auscultation sounds Killip Class IV cardiogenic shock will be assessed unmodified according to clinical routine
SECONDARY ENDPOINTS
1 In-hospital Major Adverse Cardiac Events MACE nonfatal myocardial infarction nonfatal stroke or cardiovascular death
2 Admission to intensive care unit
3 In-hospital death and death within one year
SCIENTIFIC IMPORTANCE
A link seems to exist between AE-COPD and myocardial stunningTS This is important for two main reasons
1 The cardiac condition may be masked by the respiratory symptoms and the clinical signs of AE-COPD leading to delayed or missed diagnosis of the cardiac component
2 Myocardial stunning with cardiac dysfunction may further exacerbate the patients condition leading to prolonged time to recovery due to concomitant untreated AHF and an increased risk of severe cardiac complications
Another important aspect is the treatment for AE-COPD which may include treatment with high doses of beta-2-agonists Catecholamines are part of the pathophysiological cause of myocardial stunning and catecholaminergic drugs may further aggravate myocardial stunning In fact beta-2-agonists specifically has been shown to likely trigger myocardial stunningTS Therefore the routine treatment for AE-COPD may be associated with a risk of harming patients with concomitant AE-COPD and myocardial stunning If successful the CATCH-study may improve the quality of care and outcome for patients with AE-COPD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None