Identification of Carotid Vasa Vasorum and Correlation With Acute Coronary Events

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Lantheus Medical Imaging
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01436773
First received: September 13, 2011
Last updated: September 20, 2011
Last verified: September 2011

September 13, 2011
September 20, 2011
May 2009
November 2011   (final data collection date for primary outcome measure)
Carotid Artery Adventitial Vaso Vasorum Density [ Time Frame: Measured within 1 week of enrollment. ] [ Designated as safety issue: No ]
Assessed with ultrasound contrast agent, Definity, from Lantheus Medical Imaging.
Same as current
Complete list of historical versions of study NCT01436773 on ClinicalTrials.gov Archive Site
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Identification of Carotid Vasa Vasorum and Correlation With Acute Coronary Events
Identification of Carotid Vasa Vasorum and Correlation With Acute Coronary Events

Adventitial vasa vasorum (VV) as well as intraplaque microvessels are known to be associated with atherosclerotic plaque vulnerability. Contrast-enhanced ultrasound has been validated as a technique to measure the density of VV. Previous studies have demonstrated a relationship between identification of VV and relationship to vascular events such as stroke and myocardial infarction. No previous study has reported the utilization of contrast-enhanced ultrasound identification of VV in the carotid bed as a means of identifying patients at high risk for acute coronary events.

Aims: In this study, the investigators will aim to identify VV and intraplaque microvessels along with carotid intima media thickness (CIMT), a known marker for acute coronary events. The investigators will attempt to measure the correlation of VV with acute coronary events independent of traditional cardiovascular disease (CVD) risk factors and CIMT.

Methods: 90 volunteers (30 low risk patients, 30 patients with established coronary artery disease (CAD), and 30 patients with recent acute coronary syndrome (ACS)) will be enrolled. All patients will undergo contrast-enhanced ultrasound imaging of their carotid arteries and measurement of CIMT while obtaining baseline histories and assessment of traditional risk factors for coronary artery disease. VV density and CIMT will be measured in all patients. Statistical differences in VV among the three groups will be assessed and analyses will be made to attempt to identify if VV in the carotid bed is an independent predictor of acute coronary events after controlling for CIMT and traditional risk factors.

Study population: The study population will reflect the patient population of UPMC. No individual will be excluded on the basis of race, gender, or ethnicity.

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Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Non-Probability Sample

Patients with documented coronary artery disease and/or recent acute coronary event who undergo left heart catheterization, and patients with history and previous testing that cannot rule out coronary artery disease and undergo elective left heart catheterization.

Coronary Artery Disease
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  • Recent Acute Coronary Event
    Patients admitted to the hospital for recent STEMI or NSTEMI.
  • Stable Coronary Artery Disease
    Patients with known Coronary Artery Disease without recent acute coronary event.
  • No Coronary Artery Disease
    Patients with no evidence of coronary artery disease, assessed by coronary angiography.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
December 2011
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Individuals referred for elective left heart catheterization in the past three months or individuals who have undergone recent left heart catheterization for acute coronary syndrome in the past 3 months

Exclusion Criteria:

  • Inability to provided informed consent
  • Pregnancy or of lack confirmed urine or serum B-hcg testing in pre-menopausal women under the age of 50
  • Known allergy to Definity (registered trademark)
  • Contraindications to Definity including permanent or transient right to left or bidirectional cardiac shunts, allergy to perflutren, severe pulmonary hypertension
  • Known cocaine abuse within the past year
  • History of heart transplantation
Both
18 Years and older
No
Contact: Benjamin J Sprague, MS 4126246601 spragueb@upmc.edu
United States
 
NCT01436773
CVV-ACE-01
Yes
University of Pittsburgh
University of Pittsburgh
Lantheus Medical Imaging
Principal Investigator: Flordeliza Villanueva, MD University of Pittsburgh
University of Pittsburgh
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP