NCT02350959

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

October 7, 2015

Status Verified

October 1, 2015

Enrollment Period

1 year

First QC Date

January 16, 2015

Last Update Submit

October 5, 2015

Conditions

Plaque

Keywords

Plaquecoronary computed tomography angiography

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (2)

  • the change of presence of maxLCBI(4mm) > 500

    1 year

  • the change of CT plaque vulnerability

    2years

Study Arms (2)

High dose statin

EXPERIMENTAL

In high dose statin group, atorvastatin 40mg will be used

Drug: Atorvastatin

Moderate dose statin

ACTIVE COMPARATOR

in moderate dose statin group, atorvastatin 10mg will be used

Drug: Atorvastatin

Interventions

AtorvastatinDRUG

in moderate dosea statin group, atorvastatin 10mg will be used and maintained until follow up angiography

Moderate dose statin

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 20 years of older
  • 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
  • Patients with signed informed consent
  • Confirmed coronary artery disease in computed tomography

You may not qualify if:

  • The past history of coronary artery disease (e.g., myocardial infarction, percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), etc.)
  • Less than 2-year life expectancy due to non-cardiac disease
  • If the subject cannot voluntarily agree in writing to participate in this study
  • If the subject is currently participating in any other study with another investigational drug or medical device
  • Allergic reaction to iodinated contrast media
  • 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
  • \. Contraindications of either β 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Health Insurance Service Ilsan Hospital

Goyang-si, Gyeonggi-do, South Korea

RECRUITING

Related 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.

    PMID: 24037276BACKGROUND

  • 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.

    PMID: 23785015BACKGROUND

  • 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.

    PMID: 23871513BACKGROUND

  • 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(5):426-430. doi: 10.1007/s12410-013-9224-2.

    PMID: 24098825BACKGROUND

  • 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.

    PMID: 22019821BACKGROUND

MeSH Terms

Conditions

Plaque, Amyloid

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Sanghoon Shin, M.D.

    National Health Insurance Service Ilsan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanghoon Shin, M.D.

CONTACT

82-10-8961-0707nephilla99@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Clinical Research

Study Record Dates

First Submitted

January 16, 2015

First Posted

January 30, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2017

Last Updated

October 7, 2015

Record last verified: 2015-10

Locations

KR(1)