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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Xuzhou Central Hospital
Sponsor:
Information provided by (Responsible Party):
Xuzhou Central Hospital
ClinicalTrials.gov Identifier:
NCT02219594
First received: August 10, 2014
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Coronary Heart Disease
Device: CT image for patient with suspected in-stent restenosis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Comparative Study of OCT,Gemstone CT and 320-detector Row Spiral CT for Evaluating Restenosis of Coronary Artery Stent

Resource links provided by NLM:


Further study details as provided by Xuzhou Central Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Radiation burden of the the gemstone CT or the 320-detector row spiral CT and OCT [ Time Frame: one month ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: June 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Device: CT 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.
Other Names:
  • Gemstone CT
  • 320-detector row spiral CT
  • OCT
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 .
Device: CT 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.
Other Names:
  • Gemstone CT
  • 320-detector row spiral CT
  • OCT

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02219594

Contacts
Contact: Feng chunguang, PhD +8618936376559 fcg999@163.com

Locations
China, Jiangsu
Xuzhou Central Hospital Recruiting
Xuzhou, Jiangsu, China, 221000
Contact: Feng chunguang, PhD    +8618936376559    fcg999@163.com   
Sub-Investigator: Feng chunguang, PhD         
Sponsors and Collaborators
Xuzhou Central Hospital
Investigators
Study Director: Institute of Cardiovascular Disease Xuzhou Central Hospital Southeast University
  More Information

Publications:
Responsible Party: Xuzhou Central Hospital
ClinicalTrials.gov Identifier: NCT02219594     History of Changes
Other Study ID Numbers: W201310
Study First Received: August 10, 2014
Last Updated: August 18, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Xuzhou Central Hospital:
gemstone CT
320-detector row spiral CT
optical coherence tomography(OCT)
in-stent restenosis
coronary heart disease

Additional relevant MeSH terms:
Heart Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014