Stress Testing Protocol for Coronary Heart Disease
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Cedars-Sinai Medical Center
Disqualifiers: Cardiovascular, Pulmonary, Neurological, Hypertension, Diabetes, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Microvascular coronary dysfunction (MCD) (abnormities in small blood vessels/arteries in heart) with symptoms of persistent chest pain, primarily impacts women. There are an estimated 2-3 million women in the US with MCD and about 100,000 new cases annually. Recent data from our research group suggests that coronary microvascular disease impairs the way the heart relaxes. This pilot study will attempt to exacerbate this phenotype in an effort to better understand the pathophysiology of the disease. The investigators will recruit 30 volunteers total (10 healthy calibration subjects, 10 women with microvascular disease, and 10 age-match women for the group with microvascular disease). Subjects will undergo a series of "stress" maneuvers in conjunction with advanced cardiac magnetic resonance imaging.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.
What data supports the effectiveness of the treatment Altitude simulation, Handgrip, Leg exercise, Exercise stress test, Cardiac stress test for Coronary Heart Disease?
Exercise stress testing is a well-established method for diagnosing and assessing coronary artery disease, and alternative tests like handgrip exercise have been described, though with limited sensitivity. Additionally, high-intensity, occupation-specific training has shown promise in cardiac rehabilitation, suggesting that tailored exercise regimens can be effective in managing heart conditions.
12345Is exercise stress testing safe for humans?
Exercise stress testing is generally safe for humans, with low rates of complications and mortality. Studies show that with proper safety measures and trained staff, it can be safely used even in very ill patients.
678910How does this treatment differ from other treatments for coronary heart disease?
This treatment is unique because it focuses on stress testing protocols that do not require physical exercise, using alternatives like atrial pacing and dipyridamole imaging, which are particularly useful for patients unable to perform traditional exercise tests.
19111213Eligibility Criteria
This trial is for men and women over 18 who fully understand and agree to the study's procedures. It excludes pregnant women, those unable to consent, with a history of heart/lung/brain diseases, high blood pressure, diabetes, metal implants or claustrophobia (which affects MRI testing), adherence issues, or animal dander allergies.Inclusion Criteria
Understanding and willing to sign consent form.
I am 18 years old or older.
Fully understanding and willing to undergo study procedures
Exclusion Criteria
I am currently pregnant.
You are allergic to animal fur or hair.
Your blood pressure is consistently higher than 140/90 mmHg when sitting.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Stress Testing
Participants undergo a series of stress maneuvers in conjunction with advanced cardiac magnetic resonance imaging
1-2 weeks
Multiple visits for stress testing and imaging
Follow-up
Participants are monitored for safety and effectiveness after stress testing
4 weeks
Participant Groups
The study tests how different 'stress' activities like handgrip exercises, leg exercises, and altitude simulation affect small blood vessels in the heart using advanced cardiac MRI. It aims to better understand coronary microvascular dysfunction in women with chest pain but no large artery blockages.
3Treatment groups
Experimental Treatment
Group I: calibrationExperimental Treatment3 Interventions
10 healthy individuals who will help to synchronize our imaging and stress testing maneuvers.
Group II: Women w/microvascular diseaseExperimental Treatment3 Interventions
10 women with microvascular disease
Group III: Normal controlsExperimental Treatment3 Interventions
10 age-matched women with no evidence of microvascular disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cedars-Sinai Medical CenterLos Angeles, CA
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Who Is Running the Clinical Trial?
Cedars-Sinai Medical CenterLead Sponsor
References
Evaluation of coronary artery disease in the patient unable to exercise: alternatives to exercise stress testing. [2019]Exercise stress testing is a well-established method for the diagnostic, prognostic, and functional assessment of patients with known or suspected CAD. A variety of alternative tests have been described in patients unable to perform leg exercise. Atrial pacing and dipyridamole imaging have been evaluated most extensively, and results compare favorably with those of exercise testing for diagnosing the presence of CAD. Both tests may be used to assess prognosis after myocardial infarction, and dipyridamole imaging may be useful in patients undergoing preoperative evaluation. The use of the cold pressor test and isometric handgrip exercise have also been described. However, the value of both tests is limited by a relatively low sensitivity for detecting the presence of CAD. Other testing modalities--arm ergometry, intravenous infusion of beta-adrenergic agonists, and transthoracic pacing--show promise but require further assessment to confirm their value.
Specificity of testing in a cardiac rehabilitation setting resulting in a patient's return to high-intensity outdoor activity following aortic dissection repair. [2020]A 66-year-old man who had undergone aortic dissection repair a year earlier sought to assess the feasibility of returning to the high-intensity outdoor activities he had long enjoyed. In response to his inquiry, the cardiac rehabilitation staff at Baylor Hamilton Heart and Vascular Hospital designed a comprehensive testing plan that simulated the specific movements and anticipated cardiac requirements associated with his goal activities. The activities included 1) lifting and manipulating a 50-pound suitcase, 2) hiking to the top of Half Dome in California's Yosemite National Park, and 3) scuba diving. To illustrate our approach, we describe some of the tests that were performed and report the results. After analyzing the detailed physiological data collected during testing, we provided the patient with an exercise prescription and specific guidelines that he could use to gauge his level of physical exertion during his outdoor adventures. Within approximately 6 months of testing, he successfully performed the goal activities without adverse symptoms.
Evaluating coronary artery disease noninvasively--which test for whom? [2018]The generally accepted indications for stress testing in patients with coronary artery disease include confirming the diagnosis of angina, determining the limitation of activity caused by angina, assessing prognosis in patients with known coronary artery disease, assessing perioperative risk, and evaluating responses to therapy. In patients with a clinical scenario strongly suggestive of angina, testing is not necessary to diagnose coronary artery disease. The exercise treadmill-electrocardiogram test is the oldest and most extensively used stress test and can be reliably performed in patients who are clinically stable and who have an interpretable resting electrocardiogram. The addition of myocardial imaging agents such as thallium 201, technetium Tc 99m sestamibi, and technetium Tc 99m teboroxime increases the sensitivity and specificity for detecting coronary disease. Pharmacologic agents such as dipyridamole, adenosine, and dobutamine may be used in patients who cannot exercise adequately. Myocardial ischemia can also be evaluated by echocardiography, computed tomography, or magnetic resonance imaging, especially when additional information such as left ventricular and valvular function is desired. We review the indications for the noninvasive evaluation of coronary artery disease and the rationale for selecting a diagnostic test.
High-intensity, occupation-specific training in a series of firefighters during phase II cardiac rehabilitation. [2021]Six male firefighters who were referred to phase II cardiac rehabilitation after coronary revascularization participated in a specialized regimen of high-intensity, occupation-specific training (HIOST) that simulated firefighting tasks. During each session, the electrocardiogram, heart rate, and blood pressure were monitored, and the patients were observed for adverse symptoms. No patient had to discontinue HIOST because of adverse arrhythmias or symptoms. For physicians who must make decisions about return to work, the information collected over multiple HIOST sessions might be more thorough and conclusive than the information gained during a single treadmill exercise stress test (the recommended evaluation method).
Exercise stress testing--current status. [2018]This paper is a review of the stress testing literature applying current methods of evaluation and analysis of exercise stress testing data to modern practice. Advantages and disadvantages of various methods for stress testing are discussed. Interpretation of the exercise stress test and an extensive discussion of 'false positive tests' as well as 'false negative tests' and correlation of stress testing results with other parameters of coronary heart disease provide the reader with material which is particularly relevant to frequently encountered clinical situations. The implications of a negative and adequate stress test as well as various degrees of positivity of results are reviewed. Emphasis is placed on subgrouping patients with coronary artery disease by exercise stress testing results into reasonably homogeneous and clinically relevant subgroups. The usefulness of exercise stress testing in other conditions such as valvular heart disease, cardiac rehabilitation, postoperative coronary bypass evaluation and application of radionucleotide scanning are reviewed.
Exercise testing: a prospective study of complication rates. [2019]Twenty departments of clinical physiology in Sweden, doing annually 30,000 exercise stress tests, mainly of patients, completed a questionnaire regarding how they carried out exercise testing. Bicycle ergometry was predominantely used. The criteria for inclusion of patients for exercise testing and for interruption of the test were generally wide, allowing the patient to work until symptoms limited the test. In a second part of the investigation, the departments continuously reported all complications that occurred during an 18-month period which included 50,000 exercise tests. The complication rate was 18.4, the morbidity rate was 5.2, and the mortality rate was 0.4 per 10,000 tests. The number of complications leading to permanent damage was low and it could not be proved that the exercise test had induced a higher complication rate than otherwise would have occurred during the observation period. Patients with aortic stenosis had a high risk for complications. With adequate safety measures and a well-trained staff, exercise stress testing can be regarded as a safe method to be used in the evaluation of even very ill patients.
Clinical exercise stress testing. Safety and performance guidelines. The Cardiac Society of Australia and New Zealand. [2004]Clinical exercise testing has wide application in medicine, including the assessment of functional capacity, ventilatory function, gas exchange, muscle function, and endocrine and metabolic function, and as a test for claudication in peripheral vascular disease. The major use of exercise testing, however, is as a stress test in patients with known or suspected coronary artery disease. This article outlines the minimum safety and performance guidelines for exercise stress testing with electrocardiography, although many of the safety guidelines are common to other types of exercise tests, particularly exercise stress scintigraphy and echocardiography.
Non-physician-led exercise stress testing is a safe and effective practice. [2013]Exercise stress testing is a non-invasive procedure that provides diagnostic and prognostic information for the evaluation of several pathologies, including arrhythmia provocation, assessment of exercise capacity, and coronary heart disease. Historically, exercise tests were directly supervised by physicians; however, cost-containment issues and time constraints on physicians have encouraged the use of health professionals with specific training and experience to supervise selected exercise stress tests. Evidence suggests that non-physician-led exercise stress testing is a safe and effective practice with similar morbidity and mortality rates as those performed or supervised by a physician.
Coronary artery disease--diagnosis of ischaemia: general considerations. [2019]Stress echocardiography is a well established tool for the diagnosis of coronary artery disease. It combines the provocation of myocardial ischaemia (either dynamic or nondynamic) with images of the left ventricle obtained by two-dimensional echocardiography. Different modalities can be used to unmask coronary artery disease: increase of myocardial oxygen demand (exercise, pacing, or dobutamine) or reduction in oxygen supply (dipyridamole). Each form of stress has its distinct characteristics such as haemodynamic changes, accuracy, feasibility, and adverse effect, which specifically influence the decision ¿which test for which patient'. Before engaging in the task of performing stress echocardiography, the cardiologist must have undergone special training under the supervision of an experienced stress echocardiographer, followed by an individual learning curve of ¿try out' studies without any diagnostic impact. While performing a stress echocardiographic examination one must always keep the history and risk profile of the individual patient in mind. These factors influence the pre-test likelihood of a patient having coronary artery disease, and therefore also the diagnostic merit of a stress test. While stress echocardiography is not the first test to be employed in patients with suspected coronary artery disease, it represents a diagnostic tool which, if used correctly, is likely to become the most important non-invasive technique in modern cardiology.
Low Prevalance of Major Events Adverse to Exercise Stress Echocardiography. [2018]Stress echocardiography is well validated for diagnosis and risk stratification of coronary artery disease. Exercise stress echocardiography (ESE) has been shown to be the most physiological among the modalities of stress, but its safety is not well established.
Pharmacologic manipulation of coronary vascular physiology for the evaluation of coronary artery disease. [2015]During the last forty years tremendous progress has been made in our understanding of coronary atherosclerosis and in the development of methods to characterize atherosclerotic disease burden and risk. Stress testing is designed to elucidate abnormalities in myocardial perfusion during stress due to abnormal coronary vasomotor response. We summarize the underlying determinants of normal coronary vasomotor tone as well as its responsiveness to both exercise and pharmacologic stressors. We introduce the various methods of assessing the presence of myocardial ischemia. A detailed discussion of the most commonly used stress agents as well as their clinical advantages and limitations follows.
Exercise testing in heart failure. A critical review. [2018]Exercise intolerance is one of the primary characteristics of chronic congestive heart failure (CHF). Therefore, exercise testing has been widely used in the assessment of CHF patients, both to define the severity of the disease and to assess the efficacy of pharmaceutical agents in clinical trials. A number of different exercise tests can be used, although maximal exercise testing is the most common. Maximal exercise capacity can be determined by measuring exercise duration during incremental exercise, or maximal oxygen (O2) consumption, or it can be estimated by anaerobic threshold. While baseline exercise testing in CHF patients accurately identifies and quantifies cardiac failure and determines prognosis, it is of limited value in assessing changes that occur as a result of drug therapy. A key drawback of exercise testing as a measurement of drug effect is the fact that exercise changes produced by drug intervention do not correlate well with changes in the mortality rate. Several examples of the lack of correlation between exercise testing and mortality rates have been observed in clinical trials with angiotensin converting enzyme (ACE) inhibitors and vasodilators. ACE inhibitors have a modest effect on maximal exercise capacity but they improve survival. It is thought that neuroendocrine activation more closely reflects mortality rates and also the changes in survival observed with pharmacological intervention compared with other modes of evaluation.
[Stress echocardiography--an evaluation of current status]. [2016]Exercise echocardiography, a versatile, noninvasive diagnostic test of left ventricular wall motion performed at rest and under induced stress, enables the cardiologist to detect and assess coronary artery disease. Stress-induced ischemia is thereby expressed as left ventricular regional wall motion abnormality. By using various physical (bicycle or treadmill exercise) and pharmacological (dipyridamole, dobutamine, adenosine) stress inducers, the test provides information about the localization and extent of coronary artery disease in addition to detecting stress-induced coronary insufficiency. As regards diagnostic accuracy in detecting coronary artery disease, stress echocardiography is superior to exercise electrocardiography and, according to the available data, it is comparable to perfusion scintigraphic testing. Studies have demonstrated the clinical value of stress echocardiography in detecting residual stenosis after angioplasty, for diagnosing bypass dysfunction after heart surgery, for preoperative risk assessment in noncardiac surgeries, and for obtaining prognostic information, e.g., after myocardial infarction. Preliminary studies have shown that pharmacological exercise echocardiography is able to identify viable myocardium in the early phases after acute myocardial infarction. Furthermore, it is able to predict the functional success of revascularization in chronic regional left ventricular dysfunction. In addition to the wide range of diagnostic possibilities in coronary artery disease, other notable applications include stress testing for assessment of global left ventricular pump function in patients with aortic regurgitation or cardiomyopathy.