UMIN-CTR Clinical Trial

Public title

Predictors of acute mortality in patients with cardiogenic shock treated with Impella device

Acronym

Predictors of acute mortality in patients treated with Impella device

Scientific Title

Predictors of acute mortality in patients with cardiogenic shock treated with Impella device

Scientific Title:Acronym

Predictors of acute mortality in patients treated with Impella device

Region

Japan

Condition

Cardiogenic shock

Classification by specialty

Cardiology	Emergency medicine	Intensive care medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of the study was to assess the predictive factors for acute mortality (30-day) in patients supported with Impella.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The primary endpoint of this study was defined as all-cause mortality during a 30-day follow-up period after the implantation of Impella device.

Key secondary outcomes

The secondary endpoint was the occurrence of escalated therapy (Impella 5.0 or PCPS) or died.

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with cardiogenic shock treated with Impella were included.
Cardiogenic shock was defined as the presence of all of the following:
1) hypotension (systolic blood pressure < 90 mmHg, or inotropes/vasopressors to maintain systolic blood pressure > 90 mmHg)
2) signs of end organ hypoperfusion (cool extremities, oliguria or anuria, or elevated lactate levels)
3) hemodynamic criteria represented by cardiac index of < 2.2 L/min/m2 or left ventricular end diastolic pressure of > 15 mmHg

Key exclusion criteria

Exclusion criteria included the evidence of anoxic brain injury before the implantation, unwitnessed out of hospital cardiac arrest or any cardiac arrest in which ROSC is not achieved in 30 minutes, non-cardiogenic shock (distributive, hypovolemic, or obstructive shock),or severe right ventricular dysfunction.

Target sample size

40

Name of lead principal investigator

1st name	Yuhi
Middle name
Last name	Fujimoto

Organization

Nippon Medical School Hospital

Division name

Division of Cardiovascular Intensive Care

Zip code

113-8605

Address

1-1-5, Sendagi, Bunkyo-ku, Tokyo

TEL

03-3822-2131

Email

y-fujimoto6081@nms.ac.jp

Name of contact person

1st name	Yuhi
Middle name
Last name	Fujimoto

Organization

Nippon Medical School Hospital

Division name

Division of cardiovascular medicine

Zip code

113-8605

Address

1-1-5, Sendagi, Bunkyo-ku

TEL

0338222131

Homepage URL

Email

y-fujimoto6081@nms.ac.jp

Institute

Nippon Medical School Hospital

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

Nippon Medical School Hopital

Address

1-1-5, Sendagi, Bunkyo-ku, Tokyo

Tel

0338222131

Email

y-fujimoto6081@nms.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

Date of disclosure of the study information

2020

Year

05

Month

21

Day

URL releasing protocol

no

Publication of results

Unpublished

URL related to results and publications

no

Number of participants that the trial has enrolled

67

Results

Sixty-seven with cardiogenic shock with Impella were evaluated. The 30-day mortality rate and rate of requiring escalation therapy were 24% and 18%, respectively. The P terminal force in lead V1 (PTF) was significantly higher in the deteriorated group than in the recovered group (0.052+/-0.032 vs. 0.022+/-0.010 mm*s, respectively; p<0.001). On ROC analysis, PTF>0.035 mm*s identified the deteriorated group with a sensitivity of 73% and specificity of 96% (AUC=0.93, p<0.001).

Results date posted

2022

Year

05

Month

22

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

67 with cardiogenic shock (66+/-16 years; 46 men) with Impella

Participant flow

observational study in patients with Impella device

Adverse events

none

Outcome measures

Electrocardiogram, serum lactate levels, and pulmonary artery catheterization parameters were assessed 12 hours after Impella implantation.
Patients who died or required escalation therapy within 30 days of Impella implantation were defined as the deteriorated group and the remaining as the recovered group.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2018

Year

03

Month

31

Day

Date of IRB

2018

Year

03

Month

15

Day

Anticipated trial start date

2018

Year

04

Month

01

Day

Last follow-up date

2020

Year

07

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Study Type
Prospective observetional study

Registered date

2020

Year

05

Month

20

Day

Last modified on

2022

Year

05

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046181