Evaluation of The Effects of Nebivolol in Comparison to Atenolol on Wall Shear Stress and Rupture Prone Coronary Plaques
Condition: Atherosclerosis; Endothelial Function
MeSH terms: Atherosclerosis; Rupture
Intervention: Nebivolol; Atenolol
Intervention description: 10 mg PO qday; 100 mg PO qday
Intervention MeSH terms: Atenolol; Nebivolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 29.0
Sex: All
Minimum age: 21 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      Nebivolol is a novel blood pressure lowering drug with an additional effect on the inner
      lining of blood vessels to release a compound called nitric oxide that can relax blood
      vessels. Atenolol is a blood pressure reducing agent without the ability to release nitric
      oxide and effect additional blood vessel relaxation.

      The goal of this proposal is to compare Nebivolol and Atenolol with respect to the following
      parameters:

        -  Plaque within arteries supplying the heart in terms of its volume and composition as
           assessed by ultrasound within these arteries.

        -  Ability of small arteries in the heart to open up and deliver an enhanced blood supply
           in response to drug called Adenosine (routinely used in the cardiac catheterization
           laboratory) as assessed by pressure and flow detecting catheters within these arteries.

        -  Ability of the inner lining of arteries that supply the heart to release a relaxing
           compound called nitric oxide in response to injection of Acetylcholine (also used in the
           cardiac catheterization laboratory) as assessed by squirting dye into these arteries

        -  Local forces that affect blood flow in the arteries supplying the heart as assessed by
           superimposing the above data into complex maps created offline at Georgia Institute of
           Technology.

      It is likely that Nebivolol causes the plaque within arteries supplying the heart to change
      from the 'vulnerable' type to the 'stable' type plaque. There are several features of
      "vulnerable plaques" that can be detected in arteries of the heart using intravascular
      ultrasound (a small ultrasound camera that goes in the arteries of the heart). The
      investigators hypothesis is that Nebivolol will prove superior to Atenolol in reducing
      'vulnerable plaques', improve blood flow within the small arteries and the health of inner
      lining of these arteries at the 1 year time point. The investigators plan to enroll 20
      patients into the study (26 patient including dropouts) who will be randomized in a 1:1
      manner to Nebivolol Vs Atenolol for 1 year and repeat evaluation at that time point.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with stable angina or acute coronary syndrome

          -  Moderate coronary lesion (defined as a lesion significant enough by the treating
             physician to warrant further evaluation using CFR or FFR or intravascular ultrasound
             assessment).

          -  Lesion located in the proximal 60mm of the RCA or LAD.

          -  On stable medical therapy for other cardiac risk factors.

        Exclusion Criteria:

          -  Left Main lesion greater than 50% stenosis

          -  Patients with a history of coronary artery bypass surgery

          -  Severe valvular heart disease

          -  Patients presenting with a STEMI.

          -  Inability to provide informed consent prior to randomization

          -  Creatinine >1.5

          -  Lesions located beyond 60mm in an epicardial vessel

          -  Coronary anatomy requiring CABG

          -  B-blocker, calcium channel blocker or extended-release nitrate therapy within last 48
             hours.

          -  Bradycardia (HR<50 bpm)

          -  Hypotension (SBP<100mmHg)

          -  Severe COPD by pulmonary function testing