UMIN-CTR Clinical Trial

Basic information
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
Condition	Cardiogenic shock
Classification by specialty	Cardiology Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	Nippon Medical School Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nippon Medical School Hopital
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo
Tel	0338222131
Email	y-fujimoto6081@nms.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 05 Month 21 Day

Related information
URL releasing protocol	no
Publication of results	Unpublished

Result
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

Progress
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
Other related information	Study Type Prospective observetional study

Management information
Registered date	2020 Year 05 Month 20 Day
Last modified on	2022 Year 05 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046181