Coronary Heart Disease
Conditions
Keywords
gemstone CT, 320-detector row spiral CT, optical coherence tomography(OCT), in-stent restenosis, coronary heart disease
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.
Interventions
DEVICECT image for patient with suspected in-stent restenosis
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.
Sponsors
Xuzhou Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of detection of in-stent restenosis with the gemstone CT as compared to the 320-detector row spiral CT will be investigated | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiation burden of the the gemstone CT or the 320-detector row spiral CT and OCT | 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 |
Other
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
Primary ContactFeng chunguang, PhD
Outcome results
None listed