Intracoronary Imaging With NIRS-IVUS to Characterize Arterial Plaques

This study is currently recruiting participants.
Verified October 2012 by Spectrum Health Hospitals
Sponsor:
Information provided by (Responsible Party):
Ryan Madder, MD, Spectrum Health Hospitals
ClinicalTrials.gov Identifier:
NCT01694368
First received: September 24, 2012
Last updated: October 5, 2012
Last verified: October 2012
  Purpose

To characterize atherosclerotic coronary artery plaques using advanced intra-coronary imaging with a combined near-infrared spectroscopy and intravascular ultrasound catheter before and after percutaneous intervention


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Multimodality Advanced Intracoronary Imaging With Near-infrared Spectroscopy and Intravascular Ultrasound to Characterize Coronary Artery Plaques Before and After Percutaneous Intervention

Resource links provided by NLM:


Further study details as provided by Spectrum Health Hospitals:

Estimated Enrollment: 1000
Study Start Date: November 2011
Detailed Description:

This study is being performed to characterize the composition and morphologic characteristics of atherosclerotic coronary artery plaques with intra-coronary near-infrared spectroscopy and intravascular ultrasound in patients undergoing percutaneous coronary intervention.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Coronary Artery Disease Patients

Criteria

Inclusion Criteria:

  1. Subject is at > 18 years of age
  2. Subject presents to the catheterization laboratory to undergo clinically-indicated, invasive coronary angiography
  3. Subject is willing and able to provide informed written consent
  4. Subject is found to have ≥ 1 severe coronary artery stenosis by invasive angiography and percutaneous coronary intervention is planned for definitive treatment or found to have ≥ 1 intermediate coronary artery stenosis and IVUS planned for lesion assessment
  5. Coronary anatomy is deemed suitable for combined NIRS-IVUS by the interventional cardiologist performing invasive angiography and intervention

Exclusion Criteria:

  1. Subject is pregnant or suspected to be pregnant
  2. Subject is unable to provide informed consent
  3. Subject has coronary artery anatomy deemed by interventionalist as unsuitable for NIRS-IVUS
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01694368

Locations
United States, Michigan
Spectrum Health; Frederik Meijer Heart &Vascular Institute Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Stacie VanOosterhout, MEd    616-391-1162    stacie.vanoosterhout@spectrumhealth.org   
Principal Investigator: Ryan D Madder, MD         
Sponsors and Collaborators
Spectrum Health Hospitals
  More Information

No publications provided

Responsible Party: Ryan Madder, MD, Physician, Spectrum Health Hospitals
ClinicalTrials.gov Identifier: NCT01694368     History of Changes
Other Study ID Numbers: 2011-285
Study First Received: September 24, 2012
Last Updated: October 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Spectrum Health Hospitals:
Near infrared spectroscopy; lipid core plaque; vulnerable plaque.

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014