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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011988
Receipt No. 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

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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
Institute Sakakibara Heart Institute
Institute
Department

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
URL(English) https://upload.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


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