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The Comparative Study of OCT,Gemstone CT and 320-detector Row Spiral CT for Evaluating Restenosis of Coronary Artery Stent

Primary Purpose

Coronary Heart Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CT image for patient with suspected in-stent restenosis
Sponsored by
Xuzhou Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Heart Disease focused on measuring gemstone CT, 320-detector row spiral CT, optical coherence tomography(OCT), in-stent restenosis, coronary heart disease

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 20-80, All genders
  2. Unlimited time of implantation of coronary artery stents
  3. Myocardial ischemia symptoms such as Chest tightness and/or chest pain in patients after stent implantation
  4. No clinical symptoms, but myocardial ischemia suggested by other noninvasive tests
  5. Routine re-testing 9-12 months after stent implantation.

Exclusion Criteria:

  1. Renal insufficiency (serum creatinine > 120 umol/L)
  2. Allergy of contrast
  3. Severe heart failure
  4. Uncontrollable heart rate or contraindication of taking metoprolol
  5. Unstable condition
  6. the ventricular rate beyond 70 beats / min and irregular rhythm after adjusting.

Sites / Locations

  • Xuzhou Central HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Gemstone CT

320-detector row spiral CT

Arm Description

Gemstone CT :Discovery CT750 HD(high definition) ,GE(General Electric Co.) Healthcare, Milwaukee; CT image for patient with suspected in-stent restenosis which Gemstone CT or 320-detector row spiral CT was assigned randomly to patient

320-detector row spiral CT:Aquilion One, Toshiba, Nasu, Japan. CT image for patient with suspected in-stent restenosis which Gemstone CT or 320-detector row spiral CT was assigned randomly to patient .

Outcomes

Primary Outcome Measures

Accuracy of detection of in-stent restenosis with the gemstone CT as compared to the 320-detector row spiral CT will be investigated
Masked examiners (CT specialists) will evaluate and compare the degree of in-stent restenosis of the gemstone CT and the 320-detector row spiral CT images for the presence and features of in-stent restenosis. In this study, OCT image was regard as the "gold standard" of in-stent restenosis.

Secondary Outcome Measures

Radiation burden of the the gemstone CT or the 320-detector row spiral CT and OCT
In a relatively short time,the patient will accept the two checks of CT and OCT(Interval period about 10 days).So,it is necessary to clear the reacts of these patients

Full Information

First Posted
August 10, 2014
Last Updated
August 18, 2014
Sponsor
Xuzhou Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02219594
Brief Title
The Comparative Study of OCT,Gemstone CT and 320-detector Row Spiral CT for Evaluating Restenosis of Coronary Artery Stent
Official Title
The Comparative Study of OCT,Gemstone CT and 320-detector Row Spiral CT for Evaluating Restenosis of Coronary Artery Stent
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xuzhou Central Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In-stent restenosis is a major reason of coronary heart disease recurrence .Even in drug eluting stent(DES), Restenosis rate could be up to 10% in diabetes and complex lesions though it was about 3-5% in general. It is particularly important that in-stent restenosis after implantation was early diagnosed and detected. The evaluation of OCT imaging is more accurate for narrow area calculation, more clear for narrow organization structure and more specific for detecting tissue types.It is currently the best way for restenosis histologic diagnosis.But it has many weakness such as the higher cost,an invasive test, expensive instrument, relatively complicated to operate,and etc.In this study, OCT image was regard as the "gold standard" of stent restenosis. The improvement of spatial resolution of Gemstone CT can effectively improve the imaging quality and the measurement's accuracy of coronary artery stents.The diagnostic value of in-stent restenosis of Gemstone CT is higher than of the 320-detector row spiral CT. To a certain extent, the gemstone CT can replace OCT for examining the in-stent restenosis. This study will examine the degree of in-stent restenosis by the gemstone CT and the 320-detector row spiral CT and compare the two ways on the basis of the result of OCT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
gemstone CT, 320-detector row spiral CT, optical coherence tomography(OCT), in-stent restenosis, coronary heart disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gemstone CT
Arm Type
Experimental
Arm Description
Gemstone CT :Discovery CT750 HD(high definition) ,GE(General Electric Co.) Healthcare, Milwaukee; CT image for patient with suspected in-stent restenosis which Gemstone CT or 320-detector row spiral CT was assigned randomly to patient
Arm Title
320-detector row spiral CT
Arm Type
Active Comparator
Arm Description
320-detector row spiral CT:Aquilion One, Toshiba, Nasu, Japan. CT image for patient with suspected in-stent restenosis which Gemstone CT or 320-detector row spiral CT was assigned randomly to patient .
Intervention Type
Device
Intervention Name(s)
CT image for patient with suspected in-stent restenosis
Other Intervention Name(s)
Gemstone CT, 320-detector row spiral CT, OCT
Intervention Description
Gemstone CT or 320-detector row spiral CT was assigned randomly to patient who was suspected in-stent restenosis.About after 10 days,they would accept the check of OCT which wold be the "gold standard" of in-stent restenosis.
Primary Outcome Measure Information:
Title
Accuracy of detection of in-stent restenosis with the gemstone CT as compared to the 320-detector row spiral CT will be investigated
Description
Masked examiners (CT specialists) will evaluate and compare the degree of in-stent restenosis of the gemstone CT and the 320-detector row spiral CT images for the presence and features of in-stent restenosis. In this study, OCT image was regard as the "gold standard" of in-stent restenosis.
Time Frame
On the day in which a patient receives the gemstone CT and the 320-detector row spiral CT, estimated to take 10 mins
Secondary Outcome Measure Information:
Title
Radiation burden of the the gemstone CT or the 320-detector row spiral CT and OCT
Description
In a relatively short time,the patient will accept the two checks of CT and OCT(Interval period about 10 days).So,it is necessary to clear the reacts of these patients
Time Frame
one month
Other Pre-specified Outcome Measures:
Title
Measurement of the physical characteristics of in-stent restenosis structures seen on OCT
Time Frame
On the day in which a patient receives the check of OCT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 20-80, All genders Unlimited time of implantation of coronary artery stents Myocardial ischemia symptoms such as Chest tightness and/or chest pain in patients after stent implantation No clinical symptoms, but myocardial ischemia suggested by other noninvasive tests Routine re-testing 9-12 months after stent implantation. Exclusion Criteria: Renal insufficiency (serum creatinine > 120 umol/L) Allergy of contrast Severe heart failure Uncontrollable heart rate or contraindication of taking metoprolol Unstable condition the ventricular rate beyond 70 beats / min and irregular rhythm after adjusting.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng chunguang, PhD
Phone
+8618936376559
Email
fcg999@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Institute of Cardiovascular Disease Xuzhou Central Hospital
Organizational Affiliation
Southeast University
Official's Role
Study Director
Facility Information:
Facility Name
Xuzhou Central Hospital
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng chunguang, PhD
Phone
+8618936376559
Email
fcg999@163.com
First Name & Middle Initial & Last Name & Degree
Feng chunguang, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
19000485
Citation
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Results Reference
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PubMed Identifier
18765162
Citation
Windecker S, Serruys PW, Wandel S, Buszman P, Trznadel S, Linke A, Lenk K, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Davies S, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Juni P. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial. Lancet. 2008 Sep 27;372(9644):1163-73. doi: 10.1016/S0140-6736(08)61244-1. Epub 2008 Aug 31.
Results Reference
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PubMed Identifier
10898406
Citation
Pasterkamp G, Falk E, Woutman H, Borst C. Techniques characterizing the coronary atherosclerotic plaque: influence on clinical decision making? J Am Coll Cardiol. 2000 Jul;36(1):13-21. doi: 10.1016/s0735-1097(00)00677-x.
Results Reference
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PubMed Identifier
15636110
Citation
Chau AH, Chan RC, Shishkov M, MacNeill B, Iftimia N, Tearney GJ, Kamm RD, Bouma BE, Kaazempur-Mofrad MR. Mechanical analysis of atherosclerotic plaques based on optical coherence tomography. Ann Biomed Eng. 2004 Nov;32(11):1494-503. doi: 10.1114/b:abme.0000049034.75368.4a.
Results Reference
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PubMed Identifier
19704093
Citation
Dewey M, Zimmermann E, Deissenrieder F, Laule M, Dubel HP, Schlattmann P, Knebel F, Rutsch W, Hamm B. Noninvasive coronary angiography by 320-row computed tomography with lower radiation exposure and maintained diagnostic accuracy: comparison of results with cardiac catheterization in a head-to-head pilot investigation. Circulation. 2009 Sep 8;120(10):867-75. doi: 10.1161/CIRCULATIONAHA.109.859280. Epub 2009 Aug 24.
Results Reference
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Citation
Manfrini O,Slueea M,Bugiardinl R.Optical coherence tomography[J].G ltal Cardiol(Rome),2007,8(1):28-33.
Results Reference
result
Citation
Andreini D,Pontone G,Mushtaq S,et a1.Multidetector computed tomography coronary angiography for the assessment of coronary in-stent restenosis.Am J Cardiol,2010,105:645.
Results Reference
result

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The Comparative Study of OCT,Gemstone CT and 320-detector Row Spiral CT for Evaluating Restenosis of Coronary Artery Stent

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