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PlaquePhase 4CITRUSNCT02350959

Adverse Plaque Characteristics in CCTA and TVC Imaging

A Phase 4 study testing Atorvastatin in people with Plaque, run by National Health Insurance Service Ilsan Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Plaque
What is being tested?
Atorvastatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSouth Korea
Study dates
Jan 2015to Jan 2017
Phase
Phase 4
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 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

Who cannot join

  • 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
  • 8. 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

Trial locations and contacts

1 site in 1 country.

Sanghoon Shin, M.D. contact

82-10-8961-0707

nephilla99@gmail.com

South Korea1 site, 1 recruiting

  • National Health Insurance Service Ilsan Hospital

    Goyang-si, Gyeonggi-do

    Kyung-Jin Park, 82-10-2442-4029

    Recruiting

Other trials in South Korea

About this study

Official title: Evaluation of Adverse Plaque Characteristics in Coronary Computed Tomography Angiography Using Combined Near Infrared Spectroscopy With Intravascular Ultrasound [CITRUS Study]

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.

Read the detailed 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.

Conditions
Plaque
Being tested
Atorvastatin
Keywords
Plaque, coronary computed tomography angiography
Medical subject headings
Plaque, Amyloid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtorvastatinDrug

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

  • AtorvastatinDrug

    in high dose statin group, atorvastatin 40mg will be used and maintained until follow up angiography

Study groups in NCT02350959
Study groupRoleWhat they receive
High dose statinExperimentalIn high dose statin group, atorvastatin 40mg will be used
Receives: Drug: Atorvastatin
Moderate dose statinActive comparatorin moderate dose statin group, atorvastatin 10mg will be used
Receives: Drug: Atorvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 year

  2. 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)

    Measured: maximum duration of 3 months between CT and NIRS

Secondary outcomes (2)

  1. the change of presence of maxLCBI(4mm) > 500

    vessel level comparison between initial and follow up angiography in non-target vessel

    Measured: 1 year

  2. the change of CT plaque vulnerability

    the change of Positive remodeling, Low attenuation plaque, Spotty calcification

    Measured: 2years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionJan 2016 (estimated)
  4. Study completionJan 2017 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02350959
Sponsor's protocol ID
2014-11-022
Acronym
CITRUS
Status last verified
Oct 2015
First submitted
16 Jan 2015
Last updated
7 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24037276

  • 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.

    PubMed 23785015

  • 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.

    PubMed 23871513

  • 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.

    PubMed 24098825

  • 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.

    PubMed 22019821

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Atorvastatin in people with Plaque, run by National Health Insurance Service Ilsan Hospital at 1 site in South Korea.

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 4 inclusion and 7 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 7 Oct 2015. 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 South Korea. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Sanghoon Shin, M.D. (82-10-8961-0707, nephilla99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the change of max LCBI(4mm): Lipid core burden index in 4 mm (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT02350959, which also lists 5 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 7 Oct 2015.

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