Potential markers to screen benefit after cardiac surgery
| ISRCTN | ISRCTN15411573 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15411573 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | DNro 286/13/03/02/12 |
| Sponsor | Helsinki University Central Hospital |
| Funders | Finnish government subsidies for medical research block grants, Finnish Funding Agency for Technology and Innovation |
- 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
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
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 |
| esko.kankuri@helsinki.fi |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Multicenter case-control observational study |
| Secondary study design | Case-control study |
| Study type | 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(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 31/07/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
Helsinki
00290
Finland
Tampere
33520
Finland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
