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Intracoronary Imaging With NIRS-IVUS to Characterize Arterial Plaques (NIRS-IVUS)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Ryan Madder, MD, Spectrum Health Hospitals Identifier:
First received: September 24, 2012
Last updated: October 12, 2016
Last verified: October 2016
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 Ryan Madder, MD, Spectrum Health Hospitals:

Primary Outcome Measures:
  • MACCE [ Time Frame: 5 year ]

Enrollment: 500
Study Start Date: November 2011
Estimated Study Completion Date: October 2021
Estimated Primary Completion Date: October 2021 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Please refer to this study by its identifier: NCT01694368

United States, Michigan
Spectrum Health; Frederik Meijer Heart &Vascular Institute
Grand Rapids, Michigan, United States, 49503
Sponsors and Collaborators
Spectrum Health Hospitals
Principal Investigator: Ryan D Madder, MD Spectrum Health Hospitals
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
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: October 12, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ryan Madder, MD, Spectrum Health Hospitals:
Near infrared spectroscopy; lipid core; vulnerable plaque

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases processed this record on September 21, 2017