Microvascular Disease Exercise Trial

NCT02045459 | Completed DMC

• 2 other identifiers: 168211K23HL119620-01
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Coronary Microvascular Disease

Keywords

Microvascular Disease; Exercise; Angina; Chest pain

Outcome Measures

Primary Outcomes (1)

• Change in MPR on CMR imaging from baseline with intensive medical therapy + supervised exercise versus intensive medical therapy alone.

  Determined with the use of a stress MRI after subject has been randomized and completed said randomized arm.

  20 weeks from first visit after consent is signed

Secondary Outcomes (2)

• Incremental change in MPR with exercise over intensive medical therapy alone in the exercise subgroup

  20 weeks after randomization

• Identification of reduced MPR (<2.0 ml/g/min) and borderline reduced MPR

  Within 30 days of screening visit

Study Arms (1)

Exercise Program and Medical Therapy

EXPERIMENTAL

All subjects randomized to this arm will be given intensive medical therapy including - Isosorbide mononitrate, Lisinopril, Carvedilol, and Simvastatin. After 8 weeks of ONLY medication therapy, the subjects will begin a intensive exercise program. This will be supervised on site at UVA. Also, on days that the subject is not being supervised, they will be required to keep a journal of their exercise at home.

Behavioral: Exercise Program

Interventions

Exercise Program BEHAVIORAL

Subject will be exercising on a treadmill 3x/week. Subjects progress will dictate increases/decreases in time of exercise and pace.

Exercise Program and Medical Therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - 85
• Anginal symptoms of chest pain, dyspnea on exertion, or other anginal equivalent suspected to be secondary to myocardial ischemia
• Coronary angiogram without obstructive epicardial coronary artery disease (≥50% epicardial stenosis or fractional flow reserve of \<0.80) within 6 months prior to enrollment or date of CMR #1, whichever is later and without intervening signs or symptoms suggestive of new obstructive epicardial CAD.

You may not qualify if:

• Prior CABG (due to limitations of CMR quantitative perfusion in this population)
• Prior myocardial infarction (due to its effects on myocardial flow reserve)
• Hypertrophic or restrictive cardiomyopathy
• Coronary vasospasm
• Acute coronary syndrome unless concurrent coronary angiography reveals no epicardial stenoses of \>50%
• Contraindications to CMR including - intracranial aneurysm clips, implantable pacemaker or defibrillator, metal cochlear/intraocular implants, any metallic implant not listed as magnetic resonance compatible, severe claustrophobia or other inability to tolerate a 30 minute CMR study
• GFR \< 45 ml/min/1.73² (to avoid nephrogenic systemic fibrosis and iodinated contrast dye - mediated ATN) based on creatinine within 30 days of CMR #1
• Acute kidney injury, defined by the KDIGO Clinical Practice Guidelines as an increase in serum creatinine of ≥0.3 mg/dL within 48 hours, an increase in serum creatinine ≥1.5 times baseline thought to have occurred in the past 7 days, or a urine volume \<0.5mL/kg/h for 6 hours
• Severe liver disease, paraproteinemia syndromes (such as multiple myeloma), hepatorenal syndrome, or planned liver transplantation (gadolinium contraindication)
• Pregnancy (assessed by serum beta- HCG prior to CMR) due to unclear gadolinium fetal effects
• Known hypersensitivity to regadenoson, or gadolinium
• Other contraindications to regadenoson (heart rate \< 40 bpm, 2nd or 3rd degree heart block, sick sinus syndrome without a pacemaker, severe asthma or COPD with ongoing wheezing or hospitalization within the past 6 months, systolic blood pressure \<90mmHg, recent use of dipyridamole, methylxanthine (such as aminophylline) or dipyridamole use within the past 48 hours, or caffeine within 12 hours)
• Atrial fibrillation with rapid ventricular response, frequent ectopy, or other contraindications to ECG gating
• Inability to provide informed consent
• Life expectancy of \< 2 years

Sponsors & Collaborators

• University of Virginia: lead
• Astellas Pharma Global Development, Inc.: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

University of Virginia

Charlottesville, Virginia, 22901, United States

Location

University of Virginia

Charlottesville, Virginia, 22902, United States

Location

MeSH Terms

Conditions

Microvascular Angina; Motor Activity; Angina Pectoris; Chest Pain

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Behavior; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jamieson Bourque, BA,MD,MHS

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Cardiovascular Medicine

Study Record Dates

• First Submitted: January 17, 2014
• First Posted: January 24, 2014
• Study Start: May 1, 2014
• Primary Completion: January 21, 2020
• Study Completion: May 17, 2021
• Last Updated: May 19, 2021

Record last verified: 2021-05

Locations

US (2)