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Coronary Artery DiseaseAtheroRemoIVUSNCT01789411

The European Collaborative Project on Inflammation and Vascular Wall Remodeling in Atherosclerosis - Intravascular Ultrasound Study

An observational study of Coronary Artery Disease, run by Erasmus Medical Center at 1 site in Netherlands.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 AtheroRemo-IVUS study aims to investigate the relation of coronary plaque phenotype and vulnerability as determined by intravascular ultrasound and near infrared spectroscopy with genetic profile and novel circulating biomarkers. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Drawing blood samples, Coronary intravascular ultrasound imaging and Coronary near-infrared spectroscopy
Type of treatment
Medical device
How many people
800 participants
Where
1 siteNetherlands
Study dates
Nov 2008to Dec 2013
Phase
Observational
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with acute coronary syndrome or stable angina pectoris, referred for percutaneous coronary intervention or coronary angiography

Who may be able to join

  • Patients of both sexes, more than 21 years old.
  • Patients with stable angina pectoris (CCS Class 1, 2, 3 or 4) or unstable angina pectoris (Braunwald Class 1-3, B-C) or patients with documented silent ischemia or patients with an acute myocardial infarction (STEMI and NSTEMI).
  • Patients eligible for coronary revascularization in the native coronary artery/arteries.
  • Willing and able to comply with the specified follow-up evaluation.
  • Written informed consent obtained.
  • Flow-limiting stenosis (diameter stenosis ≥50% by QCA or visual estimate) that is held responsible for angina pectoris or acute coronary syndrome
  • The study vessel has not undergone percutaneous coronary intervention in the last 8 months.

Who cannot join

  • Braunwald class IA, IIA, IIIA (angina caused by non-cardiac illness).
  • Women who are pregnant or women of childbearing potential who do not use adequate contraception.
  • Known allergies to aspirin, clopidogrel bisulfate (Plavix ®), Ticlopdine (Ticlid ®) heparin, stainless steel, copper or a sensitivity to contrast media which cannot be adequately pre-medicated.
  • Previous participation in this study or participation in another study with any investigational drug or device within the past 30 days (study participation ends after completion of the final follow-up.)
  • Life expectancy of less than one year or factors making clinical and/or angiographic follow-up difficult.
  • Planned or being status post coronary bypass surgery.
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  • Planned major non-cardiac surgery.
  • Impaired renal function (creatinine >2 mg/dl or >150 umol/L).
  • The subject has a history of bleeding diathesis or coagulopathy.
  • The subject suffered disabling stroke within the past year.
  • 3-vessel coronary artery and/or Left main disease with > 50% stenosis.
  • Minimal lumen diameter <2mm in the segments to be analyzed within the study vessel.
  • Diameter Stenosis >70% or total occlusion of the study vessel.
  • In case the study-vessel has been stented previously (>8 months ago), more than 1/3 proximal of the study vessel (at least 40mm in length) should be available for examination (i.e., outside the length of the stent plus 5mm proximal to the stent).
  • Poor LV function as assessed by Echo or by Angiography.
  • The proximal vessel is moderately to severely tortuous (moderate: 2 bends >75 degrees or one bend >90 degrees) in the segment(s) to be analyzed.
  • Known tendency to coronary vasospasm.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Erasmus MC

    Rotterdam

Other trials in Netherlands

About this study

The AtheroRemo-IVUS study aims to investigate the relation of coronary plaque phenotype and vulnerability as determined by intravascular ultrasound and near infrared spectroscopy with genetic profile and novel circulating biomarkers. AtheroRemo-IVUS is a prospective, observational, cohort study of patients who underwent coronary catheterization for acute coronary syndrome or stable angina pectoris. Prior to the catheterization procedure, blood samples were drawn for biomarker measurements and genetic analyses. Subsequent to the catheterization procedure, intravascular ultrasound is performed in a non-culprit coronary artery. In patients who are also participating in the AtheroRemo-NIRS substudy, near-infrared spectroscopy is additionally performed in the same non-culprit vessel. Primary endpoint is the presence of vulnerable plaque as determined by intravascular ultrasound. Secondary endpoint is long-term incidence of major adverse cardiac events. Results from AtheroRemo-IVUS are expected to improve our knowledge on the role of genetic profile and inflammation in the development of atherosclerosis and vulnerable plaques. Furthermore, novel biomarkers and intracoronary imaging techniques will be validated in this study.

Being tested
Drawing blood samples, Coronary intravascular ultrasound imaging, Coronary near-infrared spectroscopy
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • Drawing blood samplesOther

    Drawing blood samples from the arterial sheath prior to the standard coronary angiography procedure

  • Coronary intravascular ultrasound imagingDevice

    Coronary intravascular ultrasound imaging of a non-culprit coronary artery.

  • Coronary near-infrared spectroscopyDevice

    Near-infrared spectroscopy imaging of a non-culprit coronary artery (in patient who are included in the AtheroRemo-NIRS substudy).

Study groups in NCT01789411
Study groupRoleWhat they receive
ATHEROREMO-IVUS cohortDrawing blood samples. Coronary intravascular ultrasound imaging. Coronary near-infrared spectroscopy.
Receives: Other: Drawing blood samples; Device: Coronary intravascular ultrasound imaging; Device: Coronary near-infrared spectroscopy

What is being measured

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

  1. Vulnerable plaque as determined by intravascular ultrasound

    The primary objective is to correlate coronary plaque phenotype as determined by intravascular ultrasound with genetic profile and circulating biomarkers. Primary endpoint is the presence of vulnerable plaque as determined by intravascular ultrasound.

    Measured: cross-sectional (time of baseline coronary angiography, no follow-up)

Secondary outcomes (1)

  1. Major adverse cardiac events

    The secondary objective is to assess the prognostic value of novel biomarkers and plaque phenotypes as determined by intravascular ultrasound and near-infrared spectroscopy. Secondary endpoint is 1-year incidence of major adverse cardiac events.

    Measured: 1-year follow-up

Timeline

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

  1. First posted12 Feb 2013 (estimated)
  2. Study startNov 2008
  3. Primary completionDec 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01789411
Sponsor's protocol ID
EMC MEC 2008-210
Acronym
AtheroRemoIVUS
Status last verified
Feb 2013
First submitted
6 Feb 2013
Last updated
12 Feb 2013
Results posted
No
Data monitoring committee
No

Publications

  • Schuurman AS, Vroegindewey MM, Kardys I, Oemrawsingh RM, Garcia-Garcia HM, van Geuns RJ, Regar E, Van Mieghem NM, Ligthart J, Serruys PW, Boersma E, Akkerhuis KM. Prognostic Value of Intravascular Ultrasound in Patients With Coronary Artery Disease. J Am Coll Cardiol. 2018 Oct 23;72(17):2003-2011. doi: 10.1016/j.jacc.2018.08.2140.

    PubMed 30336823

  • de Boer S, Baran Y, Garcia-Garcia HM, Eskin I, Lenzen MJ, Kleber ME, Regar E, de Jaegere PJ, Ligthart JM, van Geuns RJ, Lehtimaki T, Laaksonen R, Boersma E, Marz W, Halperin E, Serruys PW, Koenig W. The European Collaborative Project on Inflammation and Vascular Wall Remodeling in Atherosclerosis - Intravascular Ultrasound (ATHEROREMO-IVUS) study. EuroIntervention. 2018 Jun 20;14(2):194-203. doi: 10.4244/EIJ-D-17-00180.

    PubMed 28943493

  • Oemrawsingh RM, Cheng JM, Garcia-Garcia HM, van Geuns RJ, de Boer SP, Simsek C, Kardys I, Lenzen MJ, van Domburg RT, Regar E, Serruys PW, Akkerhuis KM, Boersma E; ATHEROREMO-NIRS Investigators. Near-infrared spectroscopy predicts cardiovascular outcome in patients with coronary artery disease. J Am Coll Cardiol. 2014 Dec 16;64(23):2510-8. doi: 10.1016/j.jacc.2014.07.998.

    PubMed 25500237

  • Sonneveld MA, Cheng JM, Oemrawsingh RM, de Maat MP, Kardys I, Garcia-Garcia HM, van Geuns RJ, Regar E, Serruys PW, Boersma E, Akkerhuis KM, Leebeek FW. Von Willebrand factor in relation to coronary plaque characteristics and cardiovascular outcome. Results of the ATHEROREMO-IVUS study. Thromb Haemost. 2015 Mar;113(3):577-84. doi: 10.1160/TH14-07-0589. Epub 2014 Dec 4.

    PubMed 25472874

  • Cheng JM, Oemrawsingh RM, Akkerhuis KM, Garcia-Garcia HM, de Boer SP, Battes LC, Buljubasic N, Lenzen MJ, de Jaegere PP, van Geuns RJ, Serruys PW, Kardys I, Boersma E. Circulating chemokines in relation to coronary plaque characteristics on radiofrequency intravascular ultrasound and cardiovascular outcome. Biomarkers. 2014 Nov;19(7):611-9. doi: 10.3109/1354750X.2014.957725. Epub 2014 Sep 8.

    PubMed 25196123

  • de Boer SP, Cheng JM, Garcia-Garcia HM, Oemrawsingh RM, van Geuns RJ, Regar E, Zijlstra F, Laaksonen R, Halperin E, Kleber ME, Koenig W, Boersma E, Serruys PW. Relation of genetic profile and novel circulating biomarkers with coronary plaque phenotype as determined by intravascular ultrasound: rationale and design of the ATHEROREMO-IVUS study. EuroIntervention. 2014 Dec;10(8):953-60. doi: 10.4244/EIJY13M08_01.

    PubMed 24063848

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Erasmus Medical Center at 1 site in Netherlands.

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 7 inclusion and 17 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 12 Feb 2013. 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 Netherlands. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vulnerable plaque as determined by intravascular ultrasound (time frame: cross-sectional (time of baseline coronary angiography, no follow-up)). 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 NCT01789411, which also lists 6 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 12 Feb 2013.

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