UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011988
Receipt number R000014009
Scientific Title Prevention of Contrast Induced Nephropathy after Endovascular Therapy combined with Carbon Dioxide-digital subtraction angiography in Patients With Ilio-Femoropopliteal artery diseases
Date of disclosure of the study information 2013/10/08
Last modified on 2018/10/12 09:21:50

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Basic information

Public title

Prevention of Contrast Induced Nephropathy after Endovascular Therapy
combined with Carbon Dioxide-digital subtraction angiography in Patients
With Ilio-Femoropopliteal artery diseases

Acronym

CineCD

Scientific Title

Prevention of Contrast Induced Nephropathy after Endovascular Therapy
combined with Carbon Dioxide-digital subtraction angiography in Patients
With Ilio-Femoropopliteal artery diseases

Scientific Title:Acronym

CineCD

Region

Japan


Condition

Condition

peripheral artery disease

Classification by specialty

Cardiology Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the Prevention of Contrast Induced Nephropathy after Endovascular
Therapy combined with Carbon Dioxide-digital subtraction angiography(DSA) in
Patients With Ilio-Femoropopliteal artery diseasese.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Incidence of Contrast Induced Nephropathy

Key secondary outcomes

1)Safety of Endovascular Therapy with Carbon Dioxide-digital subtraction
angiography(DSA)
2)Comparison of ABI change after Endovascular Therapy
3)volume of contrast media, injection volume of Carbon Dioxide, Procedure
time, Endovascular Therapy related complication
4)comparison of final angiography in Endovascular Therapy


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Device,equipment Maneuver Other

Interventions/Control_1

Randomized Control arm With 60>eGFR>or=30 mL/min/1.73 m2: contrast
media-digital subtraction angiography

Interventions/Control_2

Randomized CO2 usage arm With 60>eGFR>or=30 mL/min/1.73 m2: contrast media
combined with Carbon Dioxide digital subtraction angiography

Interventions/Control_3

intervention CO2 usage arm with eGFR<30 mL/min/1.73 m2: contrast media
combined with Carbon Dioxide digital subtraction angiography

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

30 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

PAD patient recommended endovascular therapy in Patients With
Ilio-Femoropopliteal artery diseases and
estimated Glomerular Filtration Rate is less than 60ml/min./1.73m2.
not exclusion criteria patient.
patients with agreement for this study.

Key exclusion criteria

1)Life expectancy 6 months.
2)without regular dialysis
3)under 30years old
4)inappropriate patient determined from study director.
5)patient unavailable of anti platelet agents and anticoagulant.
6)Allergy of contrast agents.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Michiaki Higasitani

Organization

Sakakibara Heart Institute

Division name

Department of Cardiology

Zip code


Address

3-16-1 Asahi-cyo Futyu-shi Tokyo

TEL

042-314-3111

Email

mhigashi@shi.heart.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Clinical Trials Support Office

Organization

Sakakibara Heart Institute

Division name

Clinical Trials Support Office

Zip code


Address

3-16-1 Asahi-cyo Futyu-shi Tokyo

TEL

042-314-3111

Homepage URL


Email

tikenjim@shi.heart.or.jp


Sponsor or person

Institute

Sakakibara Heart Institute

Institute

Department

Personal name



Funding Source

Organization

Japan Research Promotion Society for Cardiovascular Disease

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2013 Year 10 Month 08 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 10 Month 07 Day

Date of IRB


Anticipated trial start date

2013 Year 10 Month 07 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 10 Month 08 Day

Last modified on

2018 Year 10 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014009


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name