Clinical trial NCT01830062: Atherosclerotic Coronary Vulnerable Plaque: Correlation With Coronary Artery Calcium
Official title: Atherosclerotic Coronary Vulnerable Plaque: Correlation With Coronary Artery Calcium
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2013-04-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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).

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 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

Primary outcomes:
measure: Correlation between CACS and LCBI
timeFrame: maximum duration of 3 months between CACS and NIRS
Secondary outcomes:
measure: Vessel level correlation of CACS and LCBI
timeFrame: maximum of 3 months between CACS and NIRS
measure: Vessel level comparison of angiographic and IVUS parameters
timeFrame: maximum of 3 months between CACS and NIRS
measure: Segment level analysis of CACS, IVUS and lipid core plaque in patients with abnormal CT
timeFrame: maximum of 3 months between CACS and NIRS
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
Study officials:
affiliation: Medstar Health Research Institute
name: Ron Waksman, MD
role: PRINCIPAL_INVESTIGATOR
References: