Predictive Value of suPAR and hsCRP on Postoperative Mortality in 951 Patients Undergoing Elective On-pump Cardiac Surgery
Conditions: Thoracic Surgery, Cardiac Surgical Procedures, Biomarkers
Sponsor: Rigshospitalet, Denmark

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<Persimune_suPAR_study1>    Version 8.6      06.02.2020 
 
 
 
  
 
 
PROTOCOL  
_____________________________________________  
 
Predictive value of suPAR and hsCRP on postoperative mortality in 951 patients 
undergoing elective on-pump cardiac surgery. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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TABLE OF CONTENTS 
 
 
Project summary 
 
 
 
 
3 
General information 
 
 
 
 
4 
Rationale & background information 
 
 
 
5 
 
Study goals and objectives 
 
 
 
 
7 
 
Study design   
 
 
 
 
8 
Methodology  
 
 
 
 
9 
Safety considerations 
 
 
 
 
10 
Follow-up  
 
 
 
 
 
10 
Data management and Statistical Analysis  
 
 
10 
Quality Assurance 
 
 
 
 
11 
Expected Outcomes of the Study 
 
 
 
11 
Dissemination of Results and Publication Policy 
 
 
11 
Duration of the Project 
 
 
 
 
12 
Problems Anticipated 
 
 
 
 
12 
Project Management 
 
 
 
 
12 
Ethics 
 
 
 
 
 
13 
Informed Consent Forms 
 
 
 
 
14 
Financing and insurance 
 
 
 
 
18 
 
 
 
 
 
 

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PROJECT SUMMARY 
Title: Predictive value of suPAR and hsCRP on postoperative mortality in 951 patients undergoing elective 
on-pump cardiac surgery. 
 
The risk models currently used to predict outcome after cardiac surgery only explain a minor part of the 
observed variation in perioperative complications between patients. A recent trend in risk modelling has been 
the addition of various biomarkers to supplement clinical risk factors. 
 
This study aims to investigate whether preoperative measurement of the inflammatory biomarkers soluble 
urokinase plasminogen activating receptor (suPAR) and High-sensitivity C-Reactive Protein (hsCRP) are 
associated with death after cardiac surgery. Further, to assess whether suPAR and hsCRP provides increased 
predictive accuracy of the clinical risk model EuroSCORE II. The purpose of the study is to gain knowledge 
on whether these inflammatory biomarkers might be able to reveal a pro-inflammatory disease state that 
represents a risk in patients undergoing cardiovascular surgery. Hence, these biomarkers may assist clinicians 
to gain more accurate risk identification and selecting compassionate treatment for high risk patients.   
 
The study design is a retrospective observational cohort study conducted at The Department of Cardiothoracic 
Anaesthesiology, Rigshospitalet, in collaboration with University of Copenhagen and PERSIMUNE Centre of 
Excellence, Rigshospitalet.  
Patients (≥18 years) undergoing elective on-pump cardiac surgery at the department of Cardiothoracic Surgery 
at Rigshospitalet, Denmark (isolated coronary artery bypass graft (CABG), single and multiple valvular 
procedures, combined CABG and valvular surgery, and others) and have given informed consent, is included. 
Exclusion criteria is; Peroperatively cancelling the surgery due to anatomic challenging findings, sudden 
change to off-pump coronary artery bypass (OPCAB) surgery, death prior to surgery and project blood samples 
not available.  
Approximately 1000 patients will be enrolled in the biobank between 2012 and 2018 and will be included in 
the study. Data collection and analysis of the biomarkers is expected to be performed in 2019. The statistical 
analysis, writing of the manuscript and submission to a peer-reviewed journal is expected to be conducted in 
primo 2020. The study is approved by The Regional Committee on Health Research Ethics and the Data 
Protection Agency.  
 
 
 
 
 
 
 
 
 
 

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GENERAL INFORMATION 
Protocol title: Predictive value of suPAR and hsCRP on postoperative mortality in 951 patients undergoing 
elective on-pump cardiac surgery. 
 
Investigators: 
Primary responsible:  
Sebastian Roed Rasmussen, MD 
Rigshospitalet, University Hospital Copenhagen 
Dept. Cardiothoracic Anaesthesiology 
Copenhagen, Denmark 
 
Senior responsible: 
Hanne Berg Ravn, MD, PhD, DMSc, Professor 
Rigshospitalet, University Hospital Copenhagen 
Dept. Cardiothoracic Anaesthesiology 
Copenhagen, Denmark 
 
Rikke Vibeke Nielsen, MD, PhD, Dept. Cardiothoracic Anaesthesiology, Rigshospitalet 
Sisse Ostrowski, MD, PhD, DMSc, Associate professor, Dept. Clinical Immunology, Rigshospitalet 
Frank Eriksson, Ass. professor, Section of Biostatistics, University of Copenhagen. 
Rasmus Møgelvang, MD, PhD, consultant, professor, centre director, the centre for cardiac, vascular, 
pulmonary and infectious diseases, Rigshospitalet 
 
Collaborators: 
PERSIMUNE, Department of Infectious Diseases, Rigshospitalet, Copenhagen University Hospital  
 
The Department of Clinical Biochemistry, Rigshospitalet, Copenhagen University Hospital  
 
Section of Biostatistics, University of Copenhagen. 
 
 
 
 
 
 
 
 

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RATIONALE & BACKGROUD INFORMATION 
Hypothesis 
We hypothesize that biomarkers reflecting a pro-inflammatory disease state at baseline; the soluble urokinase 
plasminogen activator receptor (suPAR) and high sensitivity C-reactive protein (hsCRP), can be used as 
preoperative predictors of outcome after cardiac surgery. 
Aim 
This study aims to investigate whether preoperative soluble urokinase plasminogen activating receptor 
(suPAR) and High-sensitivity C-Reactive Protein (hsCRP) levels are associated with death from any cause 
during the study period following cardiac surgery. Further, to assess whether suPAR and hsCRP provides 
increased predictive accuracy of the clinical risk model EuroSCORE II, in predicting 30 days mortality. The 
purpose of the study is to gain knowledge on whether these inflammatory biomarkers might be able to reveal 
a pro-inflammatory disease state that represents a risk in patients undergoing cardiovascular surgery. Hence, 
these biomarkers may assist clinicians to gain more accurate risk identification and selecting compassionate 
treatment for high risk patients.   
 
Background 
The risk models currently used to predict outcome after cardiac surgery only explain a minor part of the 
observed variation in perioperative complications between patients. A recent trend in risk modelling has been 
the addition of various biomarkers to supplement clinical risk factors. By identifying predictive parameters of 
postoperative outcome such as biomarkers, future prevention- and treatment strategies for high risk patients 
may be developed and reduce morbidity and mortality after cardiac surgery. These are the first steps towards 
introducing personalized medicine on the patient level and improve cost utility. 
One of the most important contributors to morbidity after cardiac surgery is the systemic inflammatory 
response syndrome (SIRS). All patients have an inflammatory response after cardiac surgery, but in about 30% 
of all patients it may lead to shock, vital organ failure, poor outcome and death (Laffey et al. 2002). The 
inflammation most likely plays a central role in the development of failure in all vital organs postoperatively 
(Laffey et al. 2002, Karkouti et al. 2009, Kertai et al. 2015). Further, patients with pro-inflammatory disease 
states preoperatively, such as coronary heart disease, heart failure and diabetes are at increased risk of SIRS 
and poor outcome after cardiac surgery. 
The ability to predict patients at high risk of postoperative complications is essential to reduce patient 
morbidity and mortality after cardiac surgery. The fundamental role of inflammation in cardiovascular disease 
has prompted interest in the predictive capability of numerous biomarkers to detect subclinical levels of 
inflammation. Formation of atherosclerotic plaques is proven to be influenced by inflammation and suPAR 
and CRP highlight different element of inflammatory biochemical pathways linked to cardiovascular risk 
(Desmedt et al., 2017). CRP is involved in the trigger process of vascular remodelling and is positively 
associated with anthropometric measures where suPAR is linked to endothelial dysfunction, subclinical organ 
damage and atherosclerotic disease burden. SuPAR and hsCRP have been studied in infectious disease as well 
as in cardiovascular disease but the relationship to cardiovascular surgery outcome has only recently been 
explored. CRP is an acute phase protein produced by the liver in response to several cytokines released from 
leukocytes during inflammation in response to infection or trauma. HsCRP measures low levels of CRP with 

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increased sensitivity. SuPAR is a novel biomarker that correlates with cardiovascular events and outperforms 
traditional markers of inflammation in prognosticating a range of cardiovascular events. SuPAR is released 
into the circulation by cleavage of the membrane-bound urokinase-type plasminogen receptor (uPAR) from 
various cells, including inflammatory and endothelial cells (Hodges et al. 2015). Patients with preoperative 
pro-inflammatory disease states, such as coronary heart disease, heart failure and diabetes are at increased risk 
of SIRS and poor outcome after cardiac surgery. New studies have indicated that patients with elevated suPAR 
undergoing aortic valve replacement surgery are at increased risk of postoperative complications and mortality 
(Hodges et al. 2018). Increased circulating concentrations of suPAR are also strongly associated with increased 
risk of cardiovascular disease, diabetes, cancer and mortality in the general population, with poor outcomes in 
critically ill patients, in non-ST-elevation myocardial infarction (NSTEMI) patients, and with recurrent 
myocardial infarction and mortality in patients with STEMI undergoing primary percutaneous coronary 
intervention (Hodges et al. 2015). Further, suPAR improves risk stratification beyond traditional risk variables 
in patients with acute ischemic cardiac events (Hodges et al. 2015). Results from our own research group 
support these findings of suPAR as a predictor for patients with acute chest pain and patients with STEMI 
undergoing primary percutaneous coronary intervention (Lyngbaek et al. 2012, Lyngbaek et al. 2013).  
HsCRP has received a lot of attention regarding screening, reclassification and prediction of treatment response 
in patients suffering from cardiovascular disease, and elevated levels of hsCRP preoperatively was found to 
be associated with increased risk of postoperative cardiovascular events after on-pump coronary artery bypass 
grafting surgery (Yousuf et al. 2013, Balciunas et al. 2009). A Danish study from 2018 has revealed, that 
elevated suPAR and CRP were associated with cardiovascular risk and had predictive value among the 60-
year old, and suPAR was of particular importance among women (Diedrichsen et at. 2018). Hence, these 
inflammatory biomarkers might be able to reveal a pro-inflammatory disease state that represents a risk in 
patients undergoing cardiovascular surgery, leading to a stronger inflammatory response with subsequent 
increased morbidity and mortality. 
 
 
 
 
 
 
 
 
 
 
 

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STUDY GOALS AND OBJECTIVES 
 
 
 
 
The goals of this study are to assess how a high pro-inflammatory disease state at baseline reflected by the 
biomarkers suPAR and hsCRP, is associated with adverse outcome after cardiac surgery. We also expect that 
suPAR and/or hsCRP can provide increased predictive accuracy of the risk model EuroSCORE II which is 
currently being used for risk stratification in many hospitals.  
Primary objective 
1. Association of preoperative suPAR values in relation to the censored time-to-event outcome “death 
from any cause” [Time Frame: from index surgery to date of data collection]  
Secondary objectives:  
1. Association of preoperative hsCRP values in relation to the censored time-to-event outcome “death 
from any cause” [Time Frame: from index surgery to date of data collection]  
2. Assess whether adding suPAR, hsCRP or combined suPAR+hsCRP measurements improves 
predictive accuracy of EuroSCORE II [Time Frame: from index surgery to 30 days postoperative] 
3. Sensitivity of the models; EuroSCORE II, suPAR, hsCRP, suPAR+hsCRP, EuroSCOREII+suPAR, 
EuroSCOREII+hsCRP and EuroSCOREII+suPAR+hsCRP in relation to the time-to-event outcome 
“death from any cause” [Time Frame: from index surgery to 30 days postoperative]   
4. Specificity of the models; EuroSCORE II, suPAR, hsCRP, suPAR+hsCRP, EuroSCOREII+suPAR, 
EuroSCOREII+hsCRP and EuroSCOREII+suPAR+hsCRP in relation to the time-to-event outcome 
“death from any cause” [Time Frame: from index surgery to 30 days postoperative]   
5. Asses association between suPAR and hsCRP measurements  
 
Other outcome measures:  
  
1. 30 days mortality measured by a yes/no question of “all-cause mortality” [Time Frame: from index 
surgery to 30 days] 
2. 1-year mortality measured by a yes/no question of “all-cause mortality” [Time Frame: from index 
surgery to 1 year] 
 
 
 
 
 
 
 
 
 
 
 

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STUDY DESIGN 
Study design:  
 
Retrospective observational cohort study. 
 
 
Place of conduction:  
 
Dept. Cardiothoracic Anaesthesiology 4141, Rigshospitalet, Copenhagen University Hospital, Denmark.  
 
Data concerning outcome measures will be obtained in collaboration with PERSIMUNE Datawarehouse and 
Biobank. 
 
Research population: 
 
The population includes adult patients (≥18 years) undergoing cardiac surgery at department of Cardiothoracic 
Surgery at Rigshospitalet, University hospital Copenhagen, Denmark. 
 
Inclusion Criteria: 
• 
Patients undergoing elective on-pump cardiac surgery (isolated coronary artery bypass graft (CABG), 
single and multiple valvular procedures, combined CABG and valvular surgery, and others) and have 
completed informed consent on delivering a blood sample for the biobank.  
Exclusion Criteria: 
• 
Peroperatively cancelling the surgery due to anatomic challenging findings, sudden change to off-
pump coronary artery bypass (OPCAB) surgery, death prior to surgery and project blood samples not 
available.  
 
 
 
 
 
 
 
 
 

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METHODOLOGY 
The following clinical information will be obtained from the electronic databases listed:   
PATS: BMI, procedure codes, CPB time and aorta clamp time, procedure date, date and time for 
admission and discharge ICU. 
ICCA: length of stay ICU (if missing in PATS)  
Biochemical data: creatinine 
The Danish National Patient Register: age, sex, date of death 
Perfusionist charts: CPB time and aorta clamp time (if missing in PATS) 
Sundhedsplatformen: type of surgery, previous PCI, AMI within 90 days of surgery, hypertension, 
diabetes mellitus, smoking status, left ventricle ejection fraction (LVEF), NYHA, CCS, date of discharge 
hospitalisation, length of stay ICU (if missing in PATS), and the following defined according to the 
EuroSCORE II; extracardiac arthropathy, mobility status, previous cardiac surgery, chronic lung disease, 
active endocarditis, critical preoperative state and pulmonary hypertension,  
 
The blood samples for the study were drawn preoperatively or within the first 24 hours of surgery (only 
preoperative data for hsCRP included), and stored in the Persimune Biobank or two other biobanks at Dept. 
Cardiothoracic Anaesthesiology and Dept. Cardiothoracic Surgery, Rigshospitalet (registered with Katrine 
Buggeskov, MD, PhD and Anne Vedel, MD, respectively). The blood samples from the established biobanks 
were obtained in relations to research projects on patients undergoing cardiac surgery. When the patients were 
giving informed consent to participate in the study they were informed about, they were also at the same time 
giving consent to the blood samples to be obtained for future research (see attached participant information). 
Blood samples stored in Persimune Biobank from patients undergoing cardiothoracic surgery has continuously 
been included by MD, PhD Rikke V. Nielsen and MD Maria Dons at the Dep. of Cardiothoracic 
Anaesthesiology. The study has been approved by the executive committee of the PERSIMUNE Centre of 
Excellence.  
In this study we will use 850 µL EDTA-plasma in matrix tubes for each patient from a total of ~1000 patients 
from all three biobanks. All tubes will be transported directly from the respective biobank to the Dep. of 
Clinical Immunology for suPAR analysis. The tubes will be kept at the Dep. of Clinical Immunology for two 
days while conducting the analysis and after analysis the tubes including excess biological material will be 
discarded. Likewise, 850 µL EDTA-plasma in matrix tubes from the ~1000 patients from all three biobanks 
will be transported directly from the respective biobank to the Dep. of Clinical Biochemistry for hsCRP 
analysis. They will be kept here for two days while conducting the analysis, and after analysis the tubes 
including excess biological material will be discarded as well. The analysis will be performed using 
commercially available analyses (suPARnostic® kit (validated to measure suPAR concentrations between 0.6 
and 22 ng/mL) (ViroGates)). HsCRP will be measured by high sensitivity CRP assays (Tina-quant hsCRP 
latex assay (validated to measure CRP concentrations between 0.3 – 20 mg) (Roche/Hitachi)). SuPAR and 
hsCRP have both proven stable in frozen samples (Riisbro et al. 2001, Nilsson et al. 2005). 
 

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SAFETY CONSIDERATIONS 
There are no health-related risks for patients in relation to the blood analyses and outcome results. Due to the 
retrospective nature of the project it will not impose any burden on  patients.  
 
FOLLOW-UP 
No physical follow-up of the study participant will be performed beyond the all-ready existing cardiac 
rehabilitation program which is being offered to all patients undergoing cardiac surgery at our site.  
 
DATA MANAGEMENT AND STATISTICAL ANALYSIS 
This study will be registered with the Danish Data Protection Agency. The law on patients’ data protection 
will be followed. Data will be handled according to the Danish Data Protection Agency and stored within the 
PERSIMUNE Data Warehouse. The study database, data analyses and reporting of data will be anonymized. 
All investigators have confidentiality. The data are only available to inspection from relevant authorities. 
Sample size and statistical analyses 
Previous studies with <500 patients have found a significant difference in mortality between suPAR quartiles 
in populations with similar mortality rates as ours (Lyngbæk et al. 2012). In a prospective observational study 
of 66 patients undergoing on-pump CABG, Balciunas et al. found that a value of hsCRP greater or equal to 
3.3 mg/L was an independent predictor of postoperative cardiovascular events in a multivariate logistic 
regression model. Approximately 1000 patients will be included in this study. 
A table 1 with patient characteristics for the entire study population will be generated presenting frequencies 
(percent), mean ± standard deviation (SD), and median (25–75% quartile), where appropriate. This table will 
include the following variables: age (continuous (years)), sex (male), body-mass-index/BMI (continuous 
(kg/m2), diabetes mellitus (NIDDM/IDDM), arterial hypertension (yes), EuroSCORE II value (continuous 
(%)), smoking status (never/previous/active), precious PCI (yes), NYHA (I-IV), CCS class 4 (yes), left 
ventricle ejection fraction/LVEF (continuous (%)), Previous cardiac surgery (yes), chronic lung disease (yes), 
acute myocardial infarction (AMI) within 90 days of surgery (yes), pulmonary hypertension (no, moderate, 
severe), weight on the intervention (isolated CABG, single non CABG, 2 procedures, 3 procedures), surgery 
on thoracic aorta (yes), baseline creatinine (continuous (µmol/L)), hsCRP (continuous (mg/L)), suPAR 
(continuous (ng/mL)),  
In addition, the following peri- and postoperative variables will be used for analysis: cardiopulmonary by-
pass/CPB time (continuous (min)), aorta clamp time (continuous (min)), length of stay – ICU (continuous 
(hours)), length of stay – Hospitalisation (continuous (days)).  
A table 2 will be generated including relevant tests for association between the individual variables mentioned 
above and continuous values of suPAR and hsCRP, respectively.  
 
We will fit Cox proportional hazards models to assess the association between preoperative suPAR and hsCRP-
values and death from any cause. The goodness-of-fit of the Cox model will be investigated and the model 
will be adapted as required to fulfil the model assumptions. The model will be adjusted for sex, age, current 
smoker, AMI within 90 days, diabetes mellitus, creatinine, CPB time and aorta clamp time. 30-days survival 

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will be modelled using logistic regression. If we cannot find Cox and/or logistic models that fit the data, 
alternative models will be considered.  
Receiver operating characteristics (ROC) curve and area under the curve (AUC) analysis will be performed 
comparing EuroSCORE II, suPAR, hsCRP, suPAR+hsCRP, EuroSCOREII+suPAR, EuroSCOREII+hsCRP 
and EuroSCOREII+suPAR+hsCRP. Sensitivity and specificity values will be included.   
Regression analysis between suPAR and hsCRP measurement will be performed.  
Kaplan-Meier survival plots will be generated for the 4 quartiles of suPAR and hsCRP, respectively.  
Two supplementary tables will be generated presenting the pre-, peri- and postoperative variables divided into 
the 4 quartiles of suPAR and hsCRP, respectively. 
A two-sided p value <0.05 will be considered significant. 
 
QUALITY ASSURANCE 
 
 
 
 
 
An internal quality control of the reliability of the biochemical analyses of the study biomarkers will be 
performed at the department of clinical biochemistry. Since the remaining clinical data is extracted from well-
established electronical databases, no internal validation on the data will be performed.        
An experienced statistician from the project group will handle the statistical analysis, to ensure quality of the 
statistical methodology and processing of data. 
 
 
 
 
EXPECTED OUTCOMES OF THE STUDY 
The results of this study are expected to provide further knowledge on the applicability of the biomarkers 
suPAR and hsCRP - specific in the setting of cardiovascular surgery. These inflammatory biomarkers might 
be able to reveal a pro-inflammatory disease state that represents a risk in patients undergoing cardiovascular 
surgery. We expect that preoperative high levels of suPAR and hsCRP are associated with death after cardiac 
surgery. 
We also expect suPAR and hsCRP to provide increased predictive accuracy of the clinical risk model 
EuroSCORE II, which is currently used in in the risk evaluation prior to surgery.   
If suPAR and hsCRP are associated with death after cardiac surgery, and if they increase the preoperative risk 
evaluation, these biomarkers may assist clinicians in selecting compassionate treatment for high risk patients 
and improve cost utility. The results of this study may lead to prospective studies evaluating the biomarkers 
and taking the first step towards introducing personalised medicine on the patient level. 
 
DISSEMINATION OF RESULT AND PUBLICATION POLICY 
Manuscript submission is expected in primo 2020. Authorship will be based on the Vancouver Authorship 
Guidelines. Both positive, negative and inconclusive findings will be published.  
 

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DURATION OF THE PROJECT 
 
 
 
 
PROBLEMS ANTICIPATED 
We are confident that the project group is capable of conducting the study including the planned blood sample 
analyses and statistical analyses. The project group is experienced in this type of research however unexpected 
problems and time delay may always occur. Since the study is fully financed, no financial barriers are 
potentially interrupting the completion of the study.   
 
PROJECT MANAGEMENT 
Sebastian Roed Rasmussen, MD, Dept. Cardiothoracic Anaesthesiology 
Role: primary investigator, concept and design, data analysis and interpretation 
 
Rikke Vibeke Nielsen, MD, PhD, Post.doc, Dept. Cardiothoracic Anaesthesiology 
Role: concept and design, collection and assembly of data, data analysis and interpretation 
 
Hanne Berg Ravn, MD, PhD, DMSc, Professor, Dept. Cardiothoracic Anaesthesiology 
Role: concept and design, administrative support, provision of study materials or patients, data analysis and 
interpretation 
 
Sisse Ostrowski, MD, PhD, DMSc, Associate professor, Dept. Clinical Immunology 
Role: concept and design, administrative support, data analysis and interpretation 
 
Frank Eriksson, Ass. Professor, Section of Biostatistics, University of Copenhagen. 
Role: concept and design, data analysis and interpretation 
 
Rasmus Møgelvang, MD, PhD, consultant, professor, centre director, the centre for cardiac, vascular, 
pulmonary and infectious diseases,  Dept. Cardiology, Rigshospitalet  
Role: concept and design, administrative support 
 
Collaborators: 
PERSIMUNE Department Infectious Diseases, Rigshospitalet, University Hospital Copenhagen. 
 
 
 
2012-2018
Patient bloodsamples 
collected to the three 
biobanks
Primo 2018
Study approved by 
The Regional 
Comitee on Health 
Research Ethics
Medio 2018
Study approved by 
The Danish Data 
Protection Agency
ultimo 2018-2019
Analysis of 
bloodsamples and 
collection of clinical 
data 
Primo 2020
Statistical analysis, 
writing the 
manuscript, and 
submision to journal 

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ETHICS 
This study will be conducted according to the principles of the Helsinki Declaration. The protocol will be 
registered in The Regional Committee on Health Research Ethics and the Data Protection Agency for approval. 
Further the investigator will report back to these institutions if any changes are made to the protocol.  
There are no additional health related risks for the patients related to these analyses as the blood samples were 
obtained during their previous cardiac procedure. Further we do not consider this study to be a burden to the 
patients. We consider the risk of coincidental findings on patients’ health status to be minimal. We will only 
measure the level of suPAR and hsCRP in relation to their cardiac surgical procedure. The suPAR and hsCRP 
levels are only of interest in relations to the historical surgical procedure. It has no relation to the present health 
state of the patient. 
The Regional Committee on Health Research Ethics has approved the study (H-18002379).  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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INFORMED CONSENT FORMS (DANISH) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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INFORMED CONSENT FORMS (ENGLISH) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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FINANCING AND INSURANCE 
The practical execution of the study is fully funded by a 100,000 DKK grant from Hjertecentrets 
Forskningsfond.