Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02350959
Other study ID # 2014-11-022
Secondary ID
Status Recruiting
Phase Phase 4
First received January 16, 2015
Last updated October 5, 2015
Start date January 2015
Est. completion date January 2017

Study information

Verified date October 2015
Source National Health Insurance Service Ilsan Hospital
Contact Sanghoon Shin, M.D.
Phone 82-10-8961-0707
Email nephilla99@gmail.com
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The present study is intended to assess the vulnerability of plaques seen on CCTA by means of TVC Imaging System and to make comparisons between plaques with adverse plaque characteristics and ones without adverse plaque characteristics in terms of plaque volume and lipid core contents.


Description:

This study is to be conducted in two phases - Phases 1 and 2. In Phase 1, the vulnerability of plaques seen on CCTA will be assessed with TVC Imaging System, and the plaque volume and lipid core contents of plaques with versus without adverse plaque characteristics will be compared. For the purpose of this study, the study of this phase will be a cross-sectional study in which the shapes of vulnerable plaques seen on CCTA will be compared to their vulnerability visualized by the TVC Imaging System.

In Phase 2, the patients with multi-vessel (polyvascular) disease of those participating in Phase 1 will be included, and the study of this phase will be a longitudinal study in which serial TVC imaging will be performed for non-target vessels, and any differences in changes of plaque vulnerability when treated with moderate-dose versus high-dose statin will be comparatively analyzed. The purpose of the present study is to determine whether there are any significant differences in changes of plaque volume and stability when treated with high-dose versus moderate-dose statin.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date January 2017
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

1. Age 20 years of older

2. Patients with typical chest pain or evidences of myocardial ischemia (e.g., stable, unstable angina, silent ischemia and positive functional study or reversible changes in the electrocardiogram (ECG) consistent with ischemia

3. Patients with signed informed consent

4. Confirmed coronary artery disease in computed tomography

Exclusion Criteria:

1. The past history of coronary artery disease (e.g., myocardial infarction, percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), etc.)

2. Less than 2-year life expectancy due to non-cardiac disease

3. If the subject cannot voluntarily agree in writing to participate in this study

4. If the subject is currently participating in any other study with another investigational drug or medical device

5. Allergic reaction to iodinated contrast media

6. Significant renal dysfunction (Serum creatinine > 1.5 mg/dl) 7 Heart rate = 80 beats per minute even after treatment with a heart rate lowering medication which disable to take CCTA

8. Contraindications of either ß blockers or nitroglycerin 9. The past history of complex congenital heart disease 10. Pregnant women or women with potential childbearing 11. Body mass index (BMI) exceeding 35 12. Irregular heartbeats which disable to take CCTA 13. Contraindications of statin due to hypersensitivity, past history of serious complication such as myopathy or increased liver enzyme more than 3 times of normal upper limit

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Atorvastatin
in moderate dosea statin group, atorvastatin 10mg will be used and maintained until follow up angiography
Atorvastatin
in high dose statin group, atorvastatin 40mg will be used and maintained until follow up angiography

Locations

Country Name City State
Korea, Republic of National Health Insurance Service Ilsan Hospital Goyang-si Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
National Health Insurance Service Ilsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

de Boer SP, Brugaletta S, Garcia-Garcia HM, Simsek C, Heo JH, Lenzen MJ, Schultz C, Regar E, Zijlstra F, Boersma E, Serruys PW. Determinants of high cardiovascular risk in relation to plaque-composition of a non-culprit coronary segment visualized by near-infrared spectroscopy in patients undergoing percutaneous coronary intervention. Eur Heart J. 2014 Feb;35(5):282-9. doi: 10.1093/eurheartj/eht378. Epub 2013 Sep 12. — View Citation

Jaguszewski M, Klingenberg R, Landmesser U. Intracoronary Near-Infrared Spectroscopy (NIRS) Imaging for Detection of Lipid Content of Coronary Plaques: Current Experience and Future Perspectives. Curr Cardiovasc Imaging Rep. 2013;6:426-430. Review. — View Citation

Madder RD, Goldstein JA, Madden SP, Puri R, Wolski K, Hendricks M, Sum ST, Kini A, Sharma S, Rizik D, Brilakis ES, Shunk KA, Petersen J, Weisz G, Virmani R, Nicholls SJ, Maehara A, Mintz GS, Stone GW, Muller JE. Detection by near-infrared spectroscopy of large lipid core plaques at culprit sites in patients with acute ST-segment elevation myocardial infarction. JACC Cardiovasc Interv. 2013 Aug;6(8):838-46. doi: 10.1016/j.jcin.2013.04.012. Epub 2013 Jul 17. — View Citation

Pu J, Mintz GS, Brilakis ES, Banerjee S, Abdel-Karim AR, Maini B, Biro S, Lee JB, Stone GW, Weisz G, Maehara A. In vivo characterization of coronary plaques: novel findings from comparing greyscale and virtual histology intravascular ultrasound and near-infrared spectroscopy. Eur Heart J. 2012 Feb;33(3):372-83. doi: 10.1093/eurheartj/ehr387. Epub 2011 Oct 20. — View Citation

Yonetsu T, Suh W, Abtahian F, Kato K, Vergallo R, Kim SJ, Jia H, McNulty I, Lee H, Jang IK. Comparison of near-infrared spectroscopy and optical coherence tomography for detection of lipid. Catheter Cardiovasc Interv. 2014 Nov 1;84(5):710-7. doi: 10.1002/ccd.25084. Epub 2013 Jul 16. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary the change of max LCBI(4mm): Lipid core burden index in 4 mm The primary endpoint for this study is the change of max LCBI(4mm) between initial and follow up angiography in non-target vessel 1 year No
Primary Correlation between vulnerable plaque on CT and max LCBI(4mm) The other primary endpoint of this study is Vessel level correlation of vulnerable plaque on CT and LCBI(4mm) maximum duration of 3 months between CT and NIRS No
Secondary the change of presence of maxLCBI(4mm) > 500 vessel level comparison between initial and follow up angiography in non-target vessel 1 year No
Secondary the change of CT plaque vulnerability the change of Positive remodeling, Low attenuation plaque, Spotty calcification 2years No
See also
  Status Clinical Trial Phase
Completed NCT02980497 - Antiplaque/Antigingivitis Efficacy of Essential Oil Mouthrinses in Six-Month Study N/A
Completed NCT02377310 - Pd/Pa vs iFR™ in an Unselected Population Referred for Invasive Angiography N/A
Not yet recruiting NCT03877705 - Xylitol Chewable Tablets Versus Xylitol Chewing Gum in Geriatric Bedridden Patients Early Phase 1
Completed NCT02666508 - Trial of Toothpaste to Reduce Plaque and Inflammation N/A
Completed NCT04921371 - Six Week Study of Experimental Mouth Rinses: Effect on Gingivitis and Plaque Phase 1
Completed NCT05138978 - Metagenomic and Metatranscriptomic Analysis of Clinical Plaque Samples Phase 2
Completed NCT05428189 - Efficacy of the Disclosing Plaque Agent as a Guide to Remove the Oral Biofilm in Orthodontic Patients. N/A
Not yet recruiting NCT05031260 - COMORAL® the Oral Irrigation Unit Clinical Trial N/A
Completed NCT05091216 - The Effects of Traditional Chinese Medicine Mouthwash Solutions on the Oral Health of Leprosy Patients N/A
Active, not recruiting NCT03022344 - DD2-Coronary Plaque Morphology and Plaque Progression N/A
Completed NCT05121909 - A Study of Experimental Mouthwashes Phase 4
Completed NCT06318819 - Plaque Removal Effectiveness of a Flossing Device Compared to the Conventional Flossing in Adults N/A
Completed NCT03989427 - The Effectiveness of Brushing and Flossing Sequence on Control of Plaque and Gingival Inflammation N/A
Completed NCT04407208 - Convalescent Plasma Therapy in Patients With COVID-19 Phase 1
Completed NCT05821712 - A New Mouthwash on Reducing Dental Plaque and Helping Prevent Gum Problems Phase 3
Completed NCT05239351 - Evaluating Performance and Safety of the Medical Device Jalucomplex in the Treatment of Facial and Neck Tissue Defects N/A
Active, not recruiting NCT05239117 - Evaluating the Performance and Safety of the Medical Device Plenhyage® in the Treatment of Dermal Tissue Defects N/A
Completed NCT05120141 - A Twelve Week Study of Experimental Mouth Rinses Phase 4
Active, not recruiting NCT05239130 - Evaluating the Performance and Safety of the Medical Device Auralya® in the Treatment of Facial Dermal Tissue Defects N/A
Completed NCT05239156 - Evaluating the Performance and Safety of the Medical Device Janesse in the Treatment of Facial Dermal Tissue Defects N/A