Potential markers to screen benefit after cardiac surgery

ISRCTN	ISRCTN15411573
DOI	https://doi.org/10.1186/ISRCTN15411573
Secondary identifying numbers	DNro 286/13/03/02/12

Submission date: 19/12/2020
Registration date: 11/01/2021
Last edited: 14/01/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Ischemic heart disease is caused by a decrease in blood flow through one or more of the blood vessels that carry oxygen to the heart. It is the leading cause of death worldwide. Despite the current awareness of the disease, there are no good clinical markers to evaluate disease severity and predict a patient’s potential benefit after cardiac surgery. This study aims to identify ischemic heart disease specific markers from right atrial appendage tissue (from the right border of the heart).

Who can participate?
Patients undergoing coronary artery bypass grafting (CABG) or aortic valve surgery

What does the study involve?
A biopsy (sample) is taken from the right atrial appendage, and patient records are analysed.

What are the possible benefits and risks of participating?
There are no clinically relevant possible benefits for participants and no significant risks associated with participation in this study.

Where is the study run from?
1. Helsinki University Hospital (Finland)
2. Tampere Heart Hospital (Finland)

When is the study starting and how long is it expected to run for?
December 2012 to July 2020

Who is funding the study?
Finnish government subsidies for medical research block grants and the Finnish Funding Agency for Technology and Innovation (Finland)

Who is the main contact:
MD, PhD Esko Kankuri
esko.kankuri@helsinki.fi

Contact information

Dr Esko Kankuri
Public

Department of Pharmacology
Faculty of Medicine
Haartmaninkatu 8
PO Box 63
Helsinki
00014
Finland

ORCID ID	0000-0002-2193-8773
Phone	+358 (0)40 7037 338
Email	esko.kankuri@helsinki.fi

Study information

Study design	Multicenter case-control observational study
Primary study design	Observational
Secondary study design	Case-control study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Atrial appendage signature RNAs associated with ischemic heart disease severity and surgical outcome
Study objectives	To explore signature RNAs associated with ischemic heart disease severity and surgical outcome after cardiac surgery.
Ethics approval(s)	Approved 12/12/2012, the Operative Ethics Committee of the Hospital District of Helsinki and Uusimaa (Biomedicum 2C, 00029 HUS; +358 (0)471 73021; tuija.sipilainen@hus.fi), ref: DNro 286/13/03/02/12
Health condition(s) or problem(s) studied	Ischemic heart disease severity and surgical outcome after cardiac surgery
Intervention	The researchers harvest samples from the right atrial appendage and perform RNA sequencing. After that, they apply bioinformatic analyses and compare RNA-sequenced data to clinical data in order to find ischemic heart disease specific markers from target tissue.
Intervention type	Other
Primary outcome measure	Differentially expressed genes in right atrial appendage tissue among patient groups, measured using Trimmomatic, EnsEMBL gene collection v82 and R bioconductor’s package edgeR after RNA sequencing after surgery. RNA sequencing data is compared to clinical data from the preoperative period and the 3-month control visit using Pearson R, Mann-Whitney U-test, Student’s t-test.
Secondary outcome measures	Differentially expressed miRNAs in right atrial appendage tissue among patient groups, measured using Trimmomatic, EnsEMBL gene collection v82 and R bioconductor’s package edgeR after RNA sequencing at after surgery. miRNA data is compared to clinical data from the preoperative period and the 3-month control visit using Pearson R, Mann-Whitney U-test, Student’s t-test.
Overall study start date	01/12/2012
Completion date	31/07/2020

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	54
Total final enrolment	48
Key inclusion criteria	Patients undergoing CABG or aortic valve surgery
Key exclusion criteria	No surgical intervention
Date of first enrolment	01/01/2014
Date of final enrolment	31/12/2015

Locations

Countries of recruitment

Finland

Study participating centres

HUS Heart and Lung Center

Haartmaninkatu 4
Helsinki
00290
Finland

Tampere Heart Hospital

Elämänaukio 1
Tampere
33520
Finland

Sponsor information

Helsinki University Central Hospital
Hospital/treatment centre

Haartmaninkatu 4
Helsinki
00290
Finland

Phone	+358 (0)9 471 72432
Email	kirjaamo@stm.fi
Website	http://www.hus.fi/en/Pages/default.aspx
"ROR"	https://ror.org/02e8hzf44

Funders

Funder type

Government

Finnish government subsidies for medical research block grants

No information available

Finnish Funding Agency for Technology and Innovation

No information available

Results and Publications

Intention to publish date	31/12/2020
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal, such as Journal of the American College of Cardiology. Statistical analysis will be available as supplementary material after publication.
IPD sharing plan	Data will be added to the Gene Expression Omnibus (GEO) data repository or another suitable data repository. Data will be available upon request from GEO. The data is anonymized, it cannot be traced back to patient information.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		02/12/2021	14/01/2022	Yes	No

Editorial Notes

14/01/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
21/12/2020: Trial's existence confirmed by the Operative Ethics Committee of the Hospital District of Helsinki and Uusimaa.