Coronary Heart DiseaseNCT02219594
The Comparative Study of OCT，Gemstone CT and 320-detector Row Spiral CT for Evaluating Restenosis of Coronary Artery Stent
A study testing CT image for patient with suspected in-stent restenosis in people with Coronary Heart Disease, run by Xuzhou Central Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- CT image for patient with suspected in-stent restenosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20-80， All genders
- Unlimited time of implantation of coronary artery stents
- Myocardial ischemia symptoms such as Chest tightness and/or chest pain in patients after stent implantation
- No clinical symptoms, but myocardial ischemia suggested by other noninvasive tests
- Routine re-testing 9-12 months after stent implantation.
Who cannot join
- Renal insufficiency (serum creatinine > 120 umol/L)
- Allergy of contrast
- Severe heart failure
- Uncontrollable heart rate or contraindication of taking metoprolol
- Unstable condition
- the ventricular rate beyond 70 beats / min and irregular rhythm after adjusting.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221000
Feng chunguang, PhD, +8618936376559, fcg999@163.com
Feng chunguang, PhD
About this study
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.
- Conditions
- Coronary Heart Disease
- Being tested
- CT image for patient with suspected in-stent restenosis
- Keywords
- gemstone CT, 320-detector row spiral CT, optical coherence tomography(OCT), in-stent restenosis, coronary heart disease
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT image for patient with suspected in-stent restenosisDevice
Also called Gemstone CT, 320-detector row spiral CT, OCT
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.
| Study group | Role | What they receive |
|---|---|---|
| Gemstone CT | Experimental | 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 Receives: Device: CT image for patient with suspected in-stent restenosis |
| 320-detector row spiral CT | Active comparator | 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 . Receives: Device: CT image for patient with suspected in-stent restenosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (1)
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
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuzhou Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Institute of Cardiovascular Disease Xuzhou Central Hospital, Study director, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219594
- Sponsor's protocol ID
- W201310
- Status last verified
- Aug 2014
- First submitted
- 10 Aug 2014
- Last updated
- 19 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19000485Windecker 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.
PubMed 18765162Pasterkamp 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.
PubMed 10898406Chau 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.
PubMed 15636110Dewey 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.
PubMed 19704093Manfrini O,Slueea M,Bugiardinl R.Optical coherence tomography[J].G ltal Cardiol(Rome)，2007,8(1):28-33．
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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Study of OCT，Gemstone CT and 320-detector Row Spiral CT for Evaluating Restenosis of Coronary Artery Stent
- ClinicalTrials.gov ID
- NCT02219594
- Acronym / sponsor ID
- W201310
- Conditions
- Coronary Heart Disease
- Keywords
- gemstone CT, 320-detector row spiral CT, optical coherence tomography(OCT), in-stent restenosis, coronary heart disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Xuzhou Central HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 19 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemstone CT | Experimental | Device: CT image for patient with suspected in-stent restenosisGemstone 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 |
| 320-detector row spiral CT | Active comparator | Device: CT image for patient with suspected in-stent restenosis320-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 . |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 20-80， All genders
- Unlimited time of implantation of coronary artery stents
- Myocardial ischemia symptoms such as Chest tightness and/or chest pain in patients after stent implantation
- No clinical symptoms, but myocardial ischemia suggested by other noninvasive tests
- Routine re-testing 9-12 months after stent implantation.
Key exclusion criteria (6 listed)
- Renal insufficiency (serum creatinine > 120 umol/L)
- Allergy of contrast
- Severe heart failure
- Uncontrollable heart rate or contraindication of taking metoprolol
- Unstable condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT image for patient with suspected in-stent restenosisAlso: Gemstone CT, 320-detector row spiral CT, OCTGemstone 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. | Device | 320-detector row spiral CT, Gemstone CT |
Primary outcome
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
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.
1 secondary outcome
Radiation burden of the the gemstone CT or the 320-detector row spiral CT and OCT
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2014.
- Background: PubMed 19000485Colombo 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.
- Background: PubMed 18765162Windecker 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.
- Background: PubMed 10898406Pasterkamp 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.
- Background: PubMed 15636110Chau 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.
- Background: PubMed 19704093Dewey 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.
- Results publicationManfrini O,Slueea M,Bugiardinl R.Optical coherence tomography[J].G ltal Cardiol(Rome)，2007,8(1):28-33．
- Results publicationAndreini 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Institute of Cardiovascular Disease Xuzhou Central Hospital study director
Southeast University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT image for patient with suspected in-stent restenosis in people with Coronary Heart Disease, run by Xuzhou Central Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng chunguang, PhD (+8618936376559, fcg999@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02219594, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2014.