UMIN-CTR Clinical Trial

Public title

Predictive factors for the recurrence of ventricular fibrillation and sustained ventricular tachycardia in patients with coronary spastic angina in multicenter observational study

Acronym

The recurrence of lethal arrhythmias in patients with coronary spastic angina in multicenter observational study.

Scientific Title

Predictive factors for the recurrence of ventricular fibrillation and sustained ventricular tachycardia in patients with coronary spastic angina in multicenter observational study

Scientific Title:Acronym

The recurrence of lethal arrhythmias in patients with coronary spastic angina in multicenter observational study.

Region

Japan

Condition

Coronary spastic angina and lethal arrhythmias

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We sought to evaluate the effects of underlying structural heart diseases on the recurrence of lethal arrhythmias in survivors with coronary spastic angina and to investigate the predictive factors for the recurrence.

Basic objectives2

Others

Basic objectives -Others

We evaluated the clinical characteristics and prognosis in patients with coronary spasm who had a previous history of ventricular fibrillation and sustained ventricular tachycardia. We investigated the mechanisms, treatment and recurrences of lethal arrhythmias.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

1) Present illness, Past history, History of smoking, Familial history
2) Laboratory test, Electrophysiological test, Non-invasive cardiac imaging test, Cardiac catheterization test.
3) Medical treatment
4) Implantable cardiac defibrillator (ICD) therapy
5) The recurrence of lethal arrhythmias and coronary ischemia and/or angina

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Survivors of ventricular fibrillation and sustained ventricular tachycardia, who were admitted to the hospitals from 1998 to February 2013 and diagnosed with coronary spastic angina.

Key exclusion criteria

1) Patients who were not diagnosed as coronary spastic angina.
2) Patients without a past history of ventricular fibrillation and sustained ventricular tachycardia.

Target sample size

60

Name of lead principal investigator

1st name	Toshiaki
Middle name
Last name	Sato

Organization

Kyorin University School of Medicine

Division name

Division of Cardiology, Second Department of Internal Medicine

Zip code

181-8611

Address

6-20-2 Shinkawa, Mitaka, Tokyo, 181-8611, Japan.

TEL

0422-47-5511

Email

toshiaki_sato@ks.kyorin-u.ac.jp

Name of contact person

1st name	Toshiaki
Middle name
Last name	Sato

Organization

Kyorin University School of Medicine

Division name

Division of Cardiology, Second Department of Internal Medicine

Zip code

181-8611

Address

6-20-2 Shinkawa, Mitaka, Tokyo, 181-8611, Japan.

TEL

0422-47-5511

Homepage URL

Email

toshiaki_sato@ks.kyorin-u.ac.jp

Institute

Kyorin University School of Medicine, Division of Cardiology, Second Department of Internal Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kyorin University ethnical committee

Address

6-20-2 Shinkawa, Mitaka-City

Tel

0422-47-5511

Email

rec@ks.kyorin-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

杏林大学病院(東京都)、慶應義塾大学病院(東京都)、仙台市立病院（宮城県)、広島市立広島市民病院(広島県)

Date of disclosure of the study information

2013

Year

03

Month

16

Day

URL releasing protocol

https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000012001

Publication of results

Unpublished

URL related to results and publications

https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000012001

Number of participants that the trial has enrolled

0

Results

The study was discontinuated because patients were not enrolled

Results date posted

2019

Year

04

Month

15

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Cardiac arrest survivor due to coronary spasm

Participant flow

retrospective observational study

Adverse events

none

Outcome measures

cardiac arrest recurrence

Plan to share IPD

IPD sharing Plan description

Recruitment status

Terminated

Date of protocol fixation

2013

Year

03

Month

11

Day

Date of IRB

2013

Year

03

Month

11

Day

Anticipated trial start date

2013

Year

03

Month

11

Day

Last follow-up date

2013

Year

03

Month

11

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

We sought to evaluate the effects of underlying structural heart diseases on the recurrence of lethal arrhythmias in survivors with coronary spastic angina. Retrospective study. Patients is consecutively enrolled into the study.

Registered date

2013

Year

03

Month

15

Day

Last modified on

2019

Year

04

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012001