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

Xuzhou Central Hospital (Xuzhou Fourth People's Hospital)

Status: Unknown

Conditions: Coronary Heart Disease

Treatments: Device: CT image for patient with suspected in-stent restenosis

Study type: Interventional

Funder types: Other

Identifiers

NCT02219594

W201310

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Gemstone CT

Experimental group

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

Treatment:

Device: CT image for patient with suspected in-stent restenosis

320-detector row spiral CT

Active Comparator group

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 .

Treatment:

Device: CT image for patient with suspected in-stent restenosis