Coronary Heart Disease Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 80 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
China | Xuzhou Central Hospital | Xuzhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Xuzhou Central Hospital |
China,
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. Review. — View 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. — View Citation
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. Spanish. — View Citation
Dewey M, Zimmermann E, Deissenrieder F, Laule M, Dübel 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. — View Citation
Manfrini O, Slucca M, Bugiardini R. [Optical coherence tomography]. G Ital Cardiol (Rome). 2007 Jan;8(1):28-33. Review. Italian. — View 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. Review. — View 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, Jüni 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Measurement of the physical characteristics of in-stent restenosis structures seen on OCT | On the day in which a patient receives the check of OCT | No | |
Primary | 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. | On the day in which a patient receives the gemstone CT and the 320-detector row spiral CT, estimated to take 10 mins | No |
Secondary | 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 | one month | Yes |
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