Stress Testing Protocol for Coronary Heart Disease

Overseen By Barbra Streisand Women's Heart Center

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Cardiovascular, Pulmonary, Neurological, Hypertension, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{1 9 11 12 13}

Research Team

Michael Nelson, PhD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility 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.

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

Treatment Details

Interventions

• Altitude simulation
• Handgrip
• Leg exercise

Trial Overview 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.

Participant Groups

Group I: calibration Experimental Treatment 3 Interventions

10 healthy individuals who will help to synchronize our imaging and stress testing maneuvers.

Group II: Women w/microvascular disease Experimental Treatment 3 Interventions

10 women with microvascular disease

Group III: Normal controls Experimental Treatment 3 Interventions

10 age-matched women with no evidence of microvascular disease

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Findings from Research

Atrial pacing and dipyridamole imaging are effective alternatives to traditional exercise stress testing for diagnosing coronary artery disease (CAD) in patients who cannot perform leg exercises, showing comparable results.

While the cold pressor test and isometric handgrip exercise have been explored, they have lower sensitivity for detecting CAD, indicating that more research is needed to validate other emerging testing methods like arm ergometry and beta-adrenergic agonist infusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of coronary artery disease in the patient unable to exercise: alternatives to exercise stress testing. Stratmann, HG., Kennedy, HL.[2019]

A comprehensive testing plan was developed for a 66-year-old man post-aortic dissection repair to assess his ability to safely return to high-intensity outdoor activities, including lifting, hiking, and scuba diving.

After tailored physiological testing and receiving an exercise prescription, the patient successfully engaged in his desired activities within 6 months without experiencing any adverse symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specificity of testing in a cardiac rehabilitation setting resulting in a patient's return to high-intensity outdoor activity following aortic dissection repair. Bartee, S., Shrestha, S., Ramos, B., et al.[2020]

Stress testing is essential for diagnosing and managing coronary artery disease, particularly in assessing prognosis and evaluating therapy responses, but is not needed when angina is clinically evident.

The exercise treadmill test remains the most common method for stress testing, and its accuracy can be enhanced with imaging agents or alternative pharmacologic agents for patients unable to exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating coronary artery disease noninvasively--which test for whom? Chou, TM., Amidon, TM.[2018]

A study involving six male firefighters undergoing phase II cardiac rehabilitation showed that high-intensity, occupation-specific training (HIOST) was safe, with no adverse arrhythmias or symptoms leading to discontinuation of the program.

The data collected from multiple HIOST sessions may provide more comprehensive insights into a patient's readiness to return to work compared to a single treadmill exercise stress test, which is the standard evaluation method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity, occupation-specific training in a series of firefighters during phase II cardiac rehabilitation. Adams, J., Cheng, D., Berbarie, RF.[2021]

This review highlights the importance of exercise stress testing in evaluating coronary heart disease, discussing both the advantages and disadvantages of various testing methods, which can help clinicians make informed decisions in practice.

The paper emphasizes the need to interpret stress test results carefully, particularly regarding false positives and negatives, and suggests subgrouping patients based on their results to improve clinical relevance and treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise stress testing--current status. Bartel, AG.[2018]

A comprehensive study involving 50,000 exercise stress tests across 20 clinical physiology departments in Sweden found that the overall complication rate was low at 18.4 per 10,000 tests, with a mortality rate of only 0.4 per 10,000 tests, indicating that exercise stress testing is generally safe even for very ill patients.

Patients with aortic stenosis were identified as having a higher risk for complications during testing, highlighting the importance of careful patient selection and monitoring during exercise stress tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise testing: a prospective study of complication rates. Atterhög, JH., Jonsson, B., Samuelsson, R.[2019]

Exercise testing is a crucial tool in medicine for evaluating various functions, particularly as a stress test for patients with coronary artery disease, helping to assess their heart health and overall functional capacity.

The article provides essential safety and performance guidelines for conducting exercise stress tests with electrocardiography, which are also applicable to other exercise testing methods like scintigraphy and echocardiography.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical exercise stress testing. Safety and performance guidelines. The Cardiac Society of Australia and New Zealand. [2004]

Exercise stress testing is a safe and effective non-invasive procedure for diagnosing and assessing various heart-related conditions, including arrhythmias and coronary heart disease.

Studies indicate that exercise stress tests supervised by trained health professionals have similar safety outcomes and effectiveness as those conducted by physicians, making it a viable alternative in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-physician-led exercise stress testing is a safe and effective practice. Sanford, KL., Williams, KM., Archbald, JA., et al.[2013]

Stress echocardiography is an effective non-invasive diagnostic tool for coronary artery disease, utilizing various stress modalities to provoke myocardial ischemia and assess heart function through echocardiography.

The success of stress echocardiography relies on the cardiologist's specialized training and understanding of the patient's history and risk factors, which are crucial for determining the appropriate testing method and interpreting results accurately.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coronary artery disease--diagnosis of ischaemia: general considerations. Schröder, K., Schultheiss, HP.[2019]

Exercise stress echocardiography (ESE) is a safe procedure for diagnosing coronary artery disease, with no reported deaths or serious complications like myocardial infarction during a study of 10,250 patients.

The most common complications were non-fatal cardiac arrhythmias, particularly supraventricular and ventricular extrasystoles, with advanced age and left atrial enlargement identified as predictors for these arrhythmias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low Prevalance of Major Events Adverse to Exercise Stress Echocardiography. Andrade, SM., Telino, CJ., Sousa, AC., et al.[2018]

Significant advancements have been made in understanding coronary atherosclerosis and assessing the risk and burden of atherosclerotic disease over the past 40 years.

Stress testing is a key method for identifying abnormalities in blood flow to the heart during physical or drug-induced stress, helping to diagnose myocardial ischemia effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacologic manipulation of coronary vascular physiology for the evaluation of coronary artery disease. Farhad, H., Murthy, VL.[2015]

Exercise testing is commonly used to assess the severity of chronic congestive heart failure (CHF) and the efficacy of treatments, but it has limitations in correlating exercise capacity improvements with actual mortality rates.

While drugs like ACE inhibitors can modestly improve exercise capacity in CHF patients, they are more effective in improving survival rates, suggesting that neuroendocrine activation may be a better indicator of patient outcomes than exercise performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise testing in heart failure. A critical review. Swedberg, K.[2018]

Exercise echocardiography is a highly effective noninvasive test for diagnosing coronary artery disease, outperforming exercise electrocardiography and showing comparable accuracy to perfusion scintigraphy, based on various stress-inducing methods.

This test not only helps in detecting coronary artery disease but also provides valuable insights for assessing heart function after procedures like angioplasty and heart surgery, and can predict outcomes after myocardial infarction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Stress echocardiography--an evaluation of current status]. Schartl, M., Beckmann, S., Bocksch, W.[2016]

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluation of coronary artery disease in the patient unable to exercise: alternatives to exercise stress testing. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Specificity of testing in a cardiac rehabilitation setting resulting in a patient's return to high-intensity outdoor activity following aortic dissection repair. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluating coronary artery disease noninvasively--which test for whom? [2018]

4. United States pubmed.ncbi.nlm.nih.gov

High-intensity, occupation-specific training in a series of firefighters during phase II cardiac rehabilitation. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Exercise stress testing--current status. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Exercise testing: a prospective study of complication rates. [2019]

7. Australia pubmed.ncbi.nlm.nih.gov

Clinical exercise stress testing. Safety and performance guidelines. The Cardiac Society of Australia and New Zealand. [2004]

8. United States pubmed.ncbi.nlm.nih.gov

Non-physician-led exercise stress testing is a safe and effective practice. [2013]

9. England pubmed.ncbi.nlm.nih.gov

Coronary artery disease--diagnosis of ischaemia: general considerations. [2019]

10. Brazil pubmed.ncbi.nlm.nih.gov

Low Prevalance of Major Events Adverse to Exercise Stress Echocardiography. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Pharmacologic manipulation of coronary vascular physiology for the evaluation of coronary artery disease. [2015]

12. New Zealand pubmed.ncbi.nlm.nih.gov

Exercise testing in heart failure. A critical review. [2018]

13. Germany pubmed.ncbi.nlm.nih.gov

[Stress echocardiography--an evaluation of current status]. [2016]