UMIN-CTR Clinical Trial

Public title

Postoperative atrial fibrillation and insulin resistance in cardiovascular surgery

Acronym

Postoperative atrial fibrillation and insulin resistance

Scientific Title

Postoperative atrial fibrillation and insulin resistance in cardiovascular surgery

Scientific Title:Acronym

Postoperative atrial fibrillation and insulin resistance

Region

Japan

Condition

valvular heart disease, angina, myocardial infarction, thoracic aortic aneurysm

Classification by specialty

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine whether postoperative atrial fibrillation and electromechanical delay correlate with systemic insulin resistance and myocardial calcium handling proteins.

Basic objectives2

Others

Basic objectives -Others

Study of molecular biology in a condition of disease

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

Correlation between postoperative atrial fibrillation and myocardial calcium handling proteins.

Key secondary outcomes

Correlation between myocardial electromechanical delay and systemic insulin resistance; Postoperative major events.

Study type

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Maneuver

Interventions/Control_1

Resection of right atrial tissue (5X5 mm) during the procedure for establishment of cardiopulmonary bypass.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients undergoing cardiovascular surgery by full sternotomy: on-pump coronary artery bypass grafting, heart valve surgery, and surgery for thoracic aortic aneurysm.

Key exclusion criteria

no informed consent; urgent or emergent surgery; under another interventional study

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Yoshiro Matsui

Organization

Hokkaido university hospital

Division name

Cardiovascular and Thoracic Surgery

Zip code

Address

Kita14, Nishi5, Kitaku, Sapporo, Japan

TEL

011-706-6042

Email

ymatsui@med.hokudai.ac.jp

Name of contact person

1st name
Middle name
Last name	Yasushige Shingu

Organization

Hokkaido university hospital

Division name

Cardiovascular and Thoracic Surgery

Zip code

Address

Kita14, Nishi5, Kitaku, Sapporo, Japan

TEL

011-706-6042

Homepage URL

Email

shingu@huhp.hokudai.ac.jp

Institute

Cardiovascular and Thoracic Surgery, Hokkaido university hospital

Institute

Department

Personal name

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

北海道大学病院

Date of disclosure of the study information

2013

Year

11

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Subjects were 38 patients who underwent cardio-thoracic surgery. Twenty-four-hours monitoring by electrocardiogram was conducted for the detection of postoperative atrial fibrillation for 7 days after surgery. Myocardial specimen excised from the right atrium during operation was quickly frozen and stored for the gene expression analysis of glucose and fatty acid metabolism. Eighteen patients (47%) presented with postoperative atrial fibrillation (POAF group). The patients in POAF group tended to have higher fasted glucose level preoperatively. The gene expression of fatty acid binding protein 3 (FABP3) - fatty acid transporter in myocytes - was significantly reduced in the POAF group than in the non-POAF group. Moreover, in the analysis of 12 patients with insulin resistance, the gene expression of cluster of differentiation 36 / fatty acid translocase (CD36) - fatty acid transporter into myocytes - tended to be higher in the POAF group than in the non-POAF group (P=0.08). We demonstrated that there is a correlation between POAF and abnormal gene expression of fatty acid metabolism in the myocardium.

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2013

Year

11

Month

19

Day

Date of IRB

Anticipated trial start date

2013

Year

11

Month

27

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

11

Month

26

Day

Last modified on

2016

Year

07

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014514