Microvascular Disease Exercise Trial
Condition: Coronary Microvascular Disease
MeSH terms: Microvascular Angina
Study type: Interventional

Summary: 
      For part of this study, we are collecting information from patients that have been
      experiencing the symptoms mentioned above. We are taking this information and creating a
      chest pain registry to follow trends and compare different patients having similar symptoms.
      We hope to gain insight into the quality of life, symptoms, and cardiac events of those who
      are having similar symptoms. The type of information we will collect includes: demographics,
      quality of life, levels of anxiety related to angina pain and cardiac events occurring within
      a 2 year period of time.

      In addition, we are performing a cardiac stress MRI for research purposes to look at the
      blood flow in the small vessels in your heart. During the stress cardiac MRI, we will give
      you a medication called Regadenoson (Lexiscan) which "stresses" your heart by dilating the
      blood vessels to your heart. This drug is approved by the U.S. Food and Drug Administration
      (FDA) for this purpose. We will then be able to measure the myocardial perfusion reserve
      (MPR) which is a measure of blood flow through the small blood vessels to see if an abnormal
      MPR and small blood vessel disease is associated with an increased risk of cardiovascular
      events, such as heart attack. At this point, there is no specific therapy for small vessel
      disease. In addition we have phase II of this study which is to determine if exercise and
      intensive medical therapy together compared to intensive medical therapy alone improves pain
      from the heart and improves overall quality of life.
    

Detailed description: 
      Cardiac angina is a major source of morbidity, affecting more than 5% of the U.S.
      population.2 It leads to more than 1.5 million hospitalizations and $190 billion in costs
      yearly.3 Obstructive coronary artery disease (CAD) is the most common cause of angina.
      However, no obstructive CAD is found on elective coronary angiography in more than 50% of
      cases.4, 5 These patients with angina but no obstructive CAD are a heterogeneous group. Some
      have noncardiac explanations for their angina or nonobstructive epicardial abnormalities such
      as coronary spasm. However, many patients with angina and no obstructive CAD have
      microvascular dysfunction from endothelial dysfunction or microvascular obstructive disease
      as the cause. These patients have microvascular angina.

      The coronary microvasculature is responsible for more than 70% of coronary resistance and
      thus plays a key role in regulating blood flow to match demand.6 Microvascular dysfunction
      can occur in the setting of dilated, hypertrophic, and restrictive cardiomyopathies. However,
      it is commonly seen in the setting of atherosclerotic risk factors or can be idiopathic.6, 7
      Microvascular dysfunction is manifest as insufficient stress myocardial blood flow and/or
      reduced myocardial perfusion reserve (MPR), the ratio of stress flow to rest flow, in
      response to a stress such as vasodilator administration. Absolute myocardial blood flow and
      MPR can be assessed noninvasively with high precision and accuracy by cardiac magnetic
      resonance (CMR) imaging Reduced MPR in patients with angina is associated with significant
      morbidity, including a high risk of cardiac events, high medical costs, and a decreased
      quality of life.Despite the poor prognosis of this population, therapeutic options to reduce
      angina and improve MPR have not been well studied. Preliminary analysis shows that statins
      may improve endothelial function. ACE-inhibitors and beta-blockers improve symptoms in
      Syndrome X, a related disorder in which patients have angina, no obstructive CAD, and
      ischemic changes but a better prognosis. Therapeutic exercise has also been used in the
      Syndrome X population, improving exercise tolerance and endothelial function and reducing
      symptom severity.Improvements in MPR could be expected with exercise due to the reduced
      resting flow and increased MPR seen in healthy volunteers and improved endothelial function
      from increased nitric oxide bioactivity in patients with probable microvascular dysfunction.
      However, no studies have examined the effect of these medications or their synergism with
      exercise on MPR, aerobic capacity, anginal symptoms, or quality of life in patients with
      angina and reduced MPR. Identification of an effective therapy that improved symptoms and
      prognosis would have dramatic impact on this highly prevalent patient population.

      The primary goal of this study is to characterize which patients with angina but no
      obstructive CAD have reduced MPR and test the effectiveness of intensive medical therapy plus
      a 12-week supervised exercise program versus intensive medical therapy alone to improve MPR,
      aerobic capacity, and the patient-centered outcomes of cardiac events, angina severity, and
      quality of life in this population with microvascular angina.
    

Intervention name(s): Exercise Program
Intervention type(s): Behavioral
Intervention description(s): Subject will be exercising on a treadmill 3x/week. Subjects progress will dictate increases/decreases in time of exercise and pace.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Microvascular Disease; Exercise; Angina; Chest pain