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

Coronary Artery Disease Clinical Trial

— AtheroRemoIVUS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01789411
• Other study ID #: EMC MEC 2008-210
• Status: Active, not recruiting
• Phase: N/A
• First received: February 6, 2013
• Last updated: February 11, 2013
• Start date: November 2008

Study information

• Verified date: February 2013
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	cross-sectional (time of baseline coronary angiography, no follow-up)	No
Secondary	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.	1-year follow-up	No