Trials / Withdrawn
WithdrawnNCT01830062
Atherosclerotic Coronary Vulnerable Plaque: Correlation With Coronary Artery Calcium
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Medstar Health Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | NIRS | Near infrared spectroscopy of at least 2 major epicardial vessels |
| OTHER | CACS | Coronary artery calcium score assessed by multi-slice computed tomography |
Timeline
- Start date
- 2013-11-01
- Primary completion
- 2019-01-01
- Completion
- 2021-06-01
- First posted
- 2013-04-12
- Last updated
- 2021-07-02
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01830062. Inclusion in this directory is not an endorsement.