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Identification of Carotid Vasa Vasorum and Correlation With Acute Coronary Events

This study is currently recruiting participants.
Verified September 2011 by University of Pittsburgh
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
History of Changes
  Purpose

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.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Identification of Carotid Vasa Vasorum and Correlation With Acute Coronary Events

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 90
Study Start Date: May 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436773

Contacts
Contact: Benjamin J Sprague, MS 4126246601 spragueb@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Benjamin J Sprague, MS     412-624-6601     spragueb@upmc.edu    
Principal Investigator: Flordeliza Villanueva, MD            
Sponsors and Collaborators
University of Pittsburgh
Lantheus Medical Imaging
Investigators
Principal Investigator: Flordeliza Villanueva, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01436773     History of Changes
Other Study ID Numbers: CVV-ACE-01
Study First Received: September 13, 2011
Last Updated: September 20, 2011
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 May 23, 2013