Clinical trial NCT02219594: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Heart Disease
Keywords: gemstone CT
320-detector row spiral CT
optical coherence tomography(OCT)
in-stent restenosis
coronary heart disease
Lead sponsor: Xuzhou Central Hospital
Sponsor class: OTHER
First posted: 2014-08-19
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy of detection of in-stent restenosis with the gemstone CT as compared to the 320-detector row spiral CT will be investigated
timeFrame: On the day in which a patient receives the gemstone CT and the 320-detector row spiral CT, estimated to take 10 mins
Secondary outcomes:
measure: Radiation burden of the the gemstone CT or the 320-detector row spiral CT and OCT
timeFrame: one month
Other outcomes:
measure: Measurement of the physical characteristics of in-stent restenosis structures seen on OCT
timeFrame: On the day in which a patient receives the check of OCT
Locations:
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
Study officials:
affiliation: Southeast University
name: Institute of Cardiovascular Disease Xuzhou Central Hospital
role: STUDY_DIRECTOR
References:
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. No abstract available. Spanish.
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.
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.
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.
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.
citation: Manfrini O, Slucca M, Bugiardini R. [Optical coherence tomography]. G Ital Cardiol (Rome). 2007 Jan;8(1):28-33. Italian.
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.