Atherosclerotic Coronary Vulnerable Plaque: Correlation With Coronary Artery Calcium

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Medstar Research Institute
Sponsor:
Information provided by (Responsible Party):
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT01830062
First received: April 8, 2013
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

The aim of this study is to compare the relationship between the coronary artery calcification assessed by MDCT with the plaque characteristics and necrotic lipid core content of non-intervened coronary segments assessed with near infrared spectroscopy (NIRS) in patients with symptomatic coronary artery disease (CAD).


Condition Intervention
Coronary Artery Disease
Other: NIRS
Other: CACS

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Atherosclerotic Coronary Vulnerable Plaque: Correlation With Coronary Artery Calcium

Resource links provided by NLM:


Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:
  • Correlation between CACS and LCBI [ Time Frame: maximum duration of 3 months between CACS and NIRS ] [ Designated as safety issue: No ]
    The primary endpoint for this study is individual patient level correlation between the total CACS of the entire coronary tree with the max LCBI4mm within the vessels imaged.


Secondary Outcome Measures:
  • Vessel level correlation of CACS and LCBI [ Time Frame: maximum of 3 months between CACS and NIRS ] [ Designated as safety issue: No ]
    Vessel level and individual coronary artery level (LM, LAD, LCx, RCA) analysis of CACS with max LCBI4mm and total LCBI for the vessel imaged

  • Vessel level comparison of angiographic and IVUS parameters [ Time Frame: maximum of 3 months between CACS and NIRS ] [ Designated as safety issue: No ]
    Vessel level comparison of angiographic and IVUS parameters with yellow plaque defined by LCBI (both max LCBI4mm and total vessel LCBI)

  • Segment level analysis of CACS, IVUS and lipid core plaque in patients with abnormal CT [ Time Frame: maximum of 3 months between CACS and NIRS ] [ Designated as safety issue: No ]
    In subset of patient where coronary angiography and NIRS is driven by patient with abnormal CT coronary angiogram, the CT angiographic parameters are utilized for Segment level analysis between the CACS, IVUS and lipid core plaque


Estimated Enrollment: 60
Study Start Date: November 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CACS and NIRS
All patients will undergo NIRS to at least 2 major epicardial vessels as a research related intervention. Patients will be considered to be enrolled in the trial upon completion NIRS evaluation. Patients who had a clinically indicated CT with CACS evaluation within 3 months prior to the cardiac catheterization with NIRS evaluation will not have any other research related interventions. Patients who have not had a clinically indicated CT with CACS within 3 months prior to the cardiac catheterization with NIRS evaluation will have the CACS after NIRS imaging prior to discharge from the hospital.
Other: NIRS
Near infrared spectroscopy of at least 2 major epicardial vessels
Other Name: LipiScan Coronary Imaging System, InfraReDx, Inc.
Other: CACS
Coronary artery calcium score assessed by multi-slice computed tomography

Detailed Description:

A total of 60 patients, from a single center, who meet all of the study inclusion criteria and none of the study exclusion criteria will be prospectively enrolled in this study. Qualifying patients will be referred to the study site for clinically indicated, non-emergent cardiac catheterization with NIRS evaluation, either proceeded or followed by coronary artery calcium score (CACS) evaluation.

Qualifying patients that are referred directly to cardiac catheterization with NIRS assessment secondary to symptoms or abnormal functional test will be sent for cardiac CACS assessment following the catheterization before discharge from the hospital. In this group, patients who require ad hoc PCI upon initial angiography will be excluded to avoid artifacts on CACS. In patients who are referred for a clinically indicated cardiac catheterization with IVUS evaluation within 3 months after MDCT with CACS, NIRS of at least two (2) major epicardial vessels will be completed prior to any (if necessary) coronary revascularization.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is ≥18 years of age
  • Patient is clinically indicated due to angina, abnormal functional test or other ischemic symptoms to undergo non-emergent cardiac catheterization with IVUS evaluation i.If the patient has not had a cardiac MDCT with CACS meeting the protocol requirements within 3 months prior to the cardiac catheterization, the patient is able to undergo CACS following LipiScan IVUS and NIRS evaluation, prior to any coronary revascularization ii. If the patient has had a cardiac MDCT evaluation with CACS meeting the protocol requirements within 3 months prior to the cardiac catheterization, LipiScan IVUS and NIRS imaging will be completed in at least two (2) major epicardial vessels prior to any coronary revascularization
  • At least two (2) major epicardial native vessels are suitable for interrogation by LipiScan IVUS imaging and NIRS evaluation, defined as:

    i.At least 30 mm of vessel that is > 2.0mm in diameter ii.No other contraindications to imaging

  • No contraindications for LipiScan IVUS and NIRS evaluation
  • No contraindications for CACS evaluation by MDCT
  • Subject must be able to provide informed consent form and comply with the protocol requirements

Exclusion Criteria:

  • Evidence of clinical hemodynamic instability in the 6 hours before either procedure
  • Prior history of percutaneous coronary intervention (PCI) with stent placement
  • Prior history of bypass grafts
  • Female subject that is pregnant or lactating
  • Any other factor that the investigator feels would put the patient at increased risk or otherwise make the patient unsuitable for participation in the protocol
  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 ClinicalTrials.gov identifier: NCT01830062

Locations
United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Ron Waksman, MD    202-877-2812    ron.waksman@medstar.net   
Principal Investigator: Ron Waksman, MD         
Sponsors and Collaborators
Medstar Research Institute
Investigators
Principal Investigator: Ron Waksman, MD Medstar Washington Hospital Center
  More Information

No publications provided

Responsible Party: Medstar Research Institute
ClinicalTrials.gov Identifier: NCT01830062     History of Changes
Other Study ID Numbers: CACS NIRS
Study First Received: April 8, 2013
Last Updated: August 8, 2014
Health Authority: United States: Institutional Review Board

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 September 18, 2014