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Trial record 1 of 1 for:    ATHEROREMO
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The European Collaborative Project on Inflammation and Vascular Wall Remodeling in Atherosclerosis - Intravascular Ultrasound Study (AtheroRemoIVUS)

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ClinicalTrials.gov Identifier: NCT01789411
Recruitment Status : Unknown
Verified February 2013 by Patrick W. Serruys, Erasmus Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : February 12, 2013
Last Update Posted : February 12, 2013
Sponsor:
Information provided by (Responsible Party):
Patrick W. Serruys, Erasmus Medical Center

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment
Coronary Artery Disease Other: Drawing blood samples Device: Coronary intravascular ultrasound imaging Device: Coronary near-infrared spectroscopy

Study Design
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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The European Collaborative Project on Inflammation and Vascular Wall Remodeling in Atherosclerosis - Intravascular Ultrasound Study
Study Start Date : November 2008
Estimated Primary Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Groups and Cohorts
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Group/Cohort Intervention/treatment
ATHEROREMO-IVUS cohort
Drawing blood samples. Coronary intravascular ultrasound imaging. Coronary near-infrared spectroscopy.
 Other: Drawing blood samples
Drawing blood samples from the arterial sheath prior to the standard coronary angiography procedure

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

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


Outcome Measures
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Primary Outcome Measures :
  1. Vulnerable plaque as determined by intravascular ultrasound [ Time Frame: cross-sectional (time of baseline coronary angiography, no follow-up) ]
    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.


Secondary Outcome Measures :
  1. Major adverse cardiac events [ Time Frame: 1-year follow-up ]
    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.


Biospecimen Retention:   Samples With DNA
Arterial blood samples

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with acute coronary syndrome or stable angina pectoris, referred for percutaneous coronary intervention or coronary angiography
Criteria

Inclusion Criteria:

  1. Patients of both sexes, more than 21 years old.
  2. 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).
  3. Patients eligible for coronary revascularization in the native coronary artery/arteries.
  4. Willing and able to comply with the specified follow-up evaluation.
  5. Written informed consent obtained.
  6. Flow-limiting stenosis (diameter stenosis ≥50% by QCA or visual estimate) that is held responsible for angina pectoris or acute coronary syndrome
  7. The study vessel has not undergone percutaneous coronary intervention in the last 8 months.

Exclusion Criteria:

  1. Braunwald class IA, IIA, IIIA (angina caused by non-cardiac illness).
  2. Women who are pregnant or women of childbearing potential who do not use adequate contraception.
  3. 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.
  4. 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.)
  5. Life expectancy of less than one year or factors making clinical and/or angiographic follow-up difficult.
  6. Planned or being status post coronary bypass surgery.
  7. Planned major non-cardiac surgery.
  8. Impaired renal function (creatinine >2 mg/dl or >150 umol/L).
  9. The subject has a history of bleeding diathesis or coagulopathy.
  10. The subject suffered disabling stroke within the past year.
  11. 3-vessel coronary artery and/or Left main disease with > 50% stenosis.
  12. Minimal lumen diameter <2mm in the segments to be analyzed within the study vessel.
  13. Diameter Stenosis >70% or total occlusion of the study vessel.
  14. 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).
  15. Poor LV function as assessed by Echo or by Angiography.
  16. 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.
  17. Known tendency to coronary vasospasm.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01789411


Locations
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Netherlands
Erasmus MC
Rotterdam, Netherlands
Sponsors and Collaborators
Erasmus Medical Center
Investigators
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Study Chair: Patrick W Serruys, MD, PhD Erasmus Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Patrick W. Serruys, MD, PhD, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT01789411    
Other Study ID Numbers: EMC MEC 2008-210
First Posted: February 12, 2013    Key Record Dates
Last Update Posted: February 12, 2013
Last Verified: February 2013
Additional relevant MeSH terms:
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Coronary Artery Disease
Atherosclerosis
Inflammation
Pathologic Processes
Coronary Disease
Myocardial Ischemia
 Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases