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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01694368
First Posted: September 27, 2012
Last Update Posted: October 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ryan Madder, MD, Spectrum Health Hospitals
  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

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.
  Eligibility

Information from the National Library of Medicine

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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
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01694368


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ryan Madder, MD, Physician, Spectrum Health Hospitals
ClinicalTrials.gov Identifier: NCT01694368     History of Changes
Other Study ID Numbers: 2011-285
First Submitted: September 24, 2012
First Posted: September 27, 2012
Last Update Posted: October 13, 2016
Last Verified: October 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
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases