Medicaldevicehub

NCT ID:	NCT01291836
NLM Download Date Description:	N/A
Study First Submitted Date:	2011-02-07
Last Update Submitted Date:	2017-08-05
Last Update Submitted Date:	2017-08-05
Result First Submitted Date:	2016-01-05
Disposition First Submitted Date:	N/A
Start Month Year:	December 2010
Start Date:	2010-12-31
Start Date Type:	N/A
Verification Month Year:	August 2017
Verification Date:	2017-08-31
Completion Month Year:	June 2015
Completion Date:	2015-06-30
Completion Date Type:	Actual
Primary Completion Month Year:	October 2013
Primary Completion Date:	2013-10-31
Primary Completion Date Type:	Actual
Study first Submitted QC Date:	2011-02-08
Study first posted Date:	2011-02-09
Result first Submitted QC Date:	2017-08-05
Result First Posted Date:	2018-02-19
Disposition First Submitted QC Date:	N/A
Disposition First Posted Date:	N/A
Last Updated Submitted QC Date:	2017-08-05
Last Updated Posted Date:	2018-02-19
Target Duration:	N/A
Study Type:	Observational
Acronym:	AKINESIS
Baseline Population:	ED presentation with symptoms of Heart Failure.
Brief Title:	Acute Kidney Injury Neutrophil Gelatinase-Associated Lipocalin Evaluation of Symptomatic Heart Failure Study
Official Title:	Acute Kidney Injury Neutrophil Gelatinase-Associated Lipocalin (N-GAL) Evaluation of Symptomatic Heart Failure Study (AKINESIS)
Overall Status:	Completed
Last Known Status:	N/A
Phase:	N/A
Enrollment:	930
Enrollment Type:	Actual
Source:	Alere San Diego
Limitation and Caveats:	N/A
Number of Arms:	N/A
Number of Groups:	N/A
Why Stopped:	N/A
Has Expanded Access:	N/A
Expanded Access Type Individual:	N/A
Expanded Access Type Intermediate:	N/A
Expanded Access Type Treatment:	N/A
Has DMC:	true
Is it FDA Regulated Drug:	N/A
Is it FDA Regulated Device:	N/A
Is it Unapproved Device:	N/A
Is PPSD:	N/A
Is US Export:	N/A
Is Biospec Retention:	Samples Without DNA
Biospec Description:	Urine Samples, Plasma Samples
Plan to Share IPD:	N/A
Plan to Share IPD Description:	N/A
IPD Time Frame:	N/A
IPD Access Criteria:	N/A
IPD URL:	N/A

NCT ID:

NCT01291836

NLM Download Date Description:

N/A

Study First Submitted Date:

2011-02-07

Last Update Submitted Date:

2017-08-05

Last Update Submitted Date:

2017-08-05

Result First Submitted Date:

2016-01-05

Disposition First Submitted Date:

N/A

Start Month Year:

December 2010

Start Date:

2010-12-31

Start Date Type:

N/A

Verification Month Year:

August 2017

Verification Date:

2017-08-31

Completion Month Year:

June 2015

Completion Date:

2015-06-30

Completion Date Type:

Actual

Primary Completion Month Year:

October 2013

Primary Completion Date:

2013-10-31

Primary Completion Date Type:

Actual

Study first Submitted QC Date:

2011-02-08

Study first posted Date:

2011-02-09

Result first Submitted QC Date:

2017-08-05

Result First Posted Date:

2018-02-19

Disposition First Submitted QC Date:

N/A

Disposition First Posted Date:

N/A

Last Updated Submitted QC Date:

2017-08-05

Last Updated Posted Date:

2018-02-19

Target Duration:

N/A

Study Type:

Observational

Acronym:

AKINESIS

Baseline Population:

ED presentation with symptoms of Heart Failure.

Brief Title:

Acute Kidney Injury Neutrophil Gelatinase-Associated Lipocalin Evaluation of Symptomatic Heart Failure Study

Official Title:

Acute Kidney Injury Neutrophil Gelatinase-Associated Lipocalin (N-GAL) Evaluation of Symptomatic Heart Failure Study (AKINESIS)

Overall Status:

Completed

Last Known Status:

N/A

Phase:

N/A

Enrollment:

930

Enrollment Type:

Actual

Source:

Alere San Diego

Limitation and Caveats:

N/A

Number of Arms:

N/A

Number of Groups:

N/A

Why Stopped:

N/A

Has Expanded Access:

N/A

Expanded Access Type Individual:

N/A

Expanded Access Type Intermediate:

N/A

Expanded Access Type Treatment:

N/A

Has DMC:

true

Is it FDA Regulated Drug:

N/A

Is it FDA Regulated Device:

N/A

Is it Unapproved Device:

N/A

Is PPSD:

N/A

Is US Export:

N/A

Is Biospec Retention:

Samples Without DNA

Biospec Description:

Urine Samples, Plasma Samples

Plan to Share IPD:

N/A

Plan to Share IPD Description:

N/A

IPD Time Frame:

N/A

IPD Access Criteria:

N/A

IPD URL:

N/A

Detailed Result for NCT01291836