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

February 11, 2013 updated by: Patrick W. Serruys, Erasmus Medical Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
cross-sectional (time of baseline coronary angiography, no follow-up)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
1-year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Erasmus Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Patrick W Serruys, MD, PhD, Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2008

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EMC MEC 2008-210

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings