Intracoronary Imaging With NIRS-IVUS to Characterize Arterial Plaques

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Spectrum Health Hospitals
Information provided by (Responsible Party):
Ryan Madder, MD, Spectrum Health Hospitals Identifier:
First received: September 24, 2012
Last updated: November 18, 2015
Last verified: November 2015
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

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

Further study details as provided by Spectrum Health Hospitals:

Primary Outcome Measures:
  • MACCE [ Time Frame: 5 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: November 2011
Estimated Study Completion Date: July 2025
Estimated Primary Completion Date: July 2025 (Final data collection date for primary outcome measure)
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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01694368

United States, Michigan
Spectrum Health; Frederik Meijer Heart &Vascular Institute Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Stacie VanOosterhout, MEd    616-391-1162   
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 Identifier: NCT01694368     History of Changes
Other Study ID Numbers: 2011-285
Study First Received: September 24, 2012
Last Updated: November 18, 2015
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
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Heart Diseases
Vascular Diseases processed this record on November 30, 2015