- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02219594
The Comparative Study of OCT,Gemstone CT and 320-detector Row Spiral CT for Evaluating Restenosis of Coronary Artery Stent
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Jiangsu
-
Xuzhou, Jiangsu, China, 221000
- Recruiting
- Xuzhou Central Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gemstone CT
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
|
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.
Other Names:
|
Active Comparator: 320-detector row spiral CT
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 .
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of detection of in-stent restenosis with the gemstone CT as compared to the 320-detector row spiral CT will be investigated
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
|
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.
|
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiation burden of the the gemstone CT or the 320-detector row spiral CT and OCT
Time Frame: one month
|
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
|
one month
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
On the day in which a patient receives the check of OCT
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- Colombo A, Latib A. [Treatment of drug-eluting stent restenosis with another drug-eluting stent: do not fail the second time!]. Rev Esp Cardiol. 2008 Nov;61(11):1120-2. No abstract available. Spanish.
- 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.
- 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.
- Manfrini O, Slucca M, Bugiardini R. [Optical coherence tomography]. G Ital Cardiol (Rome). 2007 Jan;8(1):28-33. Italian.
- Andreini D, Pontone G, Mushtaq S, Pepi M, Bartorelli AL. Multidetector computed tomography coronary angiography for the assessment of coronary in-stent restenosis. Am J Cardiol. 2010 Mar 1;105(5):645-55. doi: 10.1016/j.amjcard.2009.10.046.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- W201310
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Heart Disease
-
Peking University Third HospitalCompletedCoronary Microvascular Dysfunction | Obstructive Coronary Heart DiseaseChina
-
Shenyang Northern HospitalNot yet recruitingCoronary Heart Disease (CHD)China
-
Johns Hopkins UniversityCanon Medical Systems, USARecruiting
-
MedImmune LLCCompletedStable Coronary Heart DiseaseUnited States
-
Medical University of LodzBaxter Healthcare CorporationUnknownCHD - Coronary Heart DiseasePoland
-
University of ZurichCompletedStable Coronary Heart DiseaseSwitzerland
-
Hamad Medical CorporationMayo ClinicCompleted
-
Centro de estudios en Cardiologia IntervencionistaCompletedCoronary Heart Disease | Coronary RestenosisArgentina
-
Deutsches Herzzentrum MuenchenCompletedCoronary Heart DiseaseGermany
-
Henan Institute of Cardiovascular EpidemiologyNot yet recruitingStable Coronary Heart Disease
Clinical Trials on CT image for patient with suspected in-stent restenosis
-
Thomas GuerreroCompletedPulmonary Embolism | Pulmonary ThromboembolismsUnited States
-
The First Affiliated Hospital with Nanjing Medical...RecruitingCoronary Heart DiseaseChina
-
University Hospital, GrenobleNot yet recruitingCoronary Artery Disease | Cardiology
-
Centre Leon BerardUnknown
-
Hospices Civils de LyonRecruitingPregnancy Related | Cesarean Section Complications | AnesthesiaFrance
-
Navidea BiopharmaceuticalsCompletedArthritis, RheumatoidUnited States
-
Instituto de Investigacion Sanitaria La FeSociedad Española de Neumología y Cirugía Torácica; Sociedad Valenciana de... and other collaboratorsRecruitingCommunity-acquired PneumoniaSpain
-
Memorial Sloan Kettering Cancer CenterActive, not recruitingConfirmed Diagnosis of ß-thalassemia MajorUnited States
-
Assistance Publique - Hôpitaux de ParisWithdrawnPulmonary Arterial Hypertension With Congenital Cardiac Shunt