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Trial record 1 of 130 for:    stress testing OR exercise echocardiogram OR myocardial perfusion imaging | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed
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Arm Exercise Versus Pharmacologic Stress Testing for Clinical Outcome (ArmCrank)

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ClinicalTrials.gov Identifier: NCT03449888
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : July 31, 2018
Sponsor:
Collaborator:
VA St. Louis Health Care System
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
This is a 5-year clinical trial to evaluate whether arm exercise electrocardiographic (ECG) stress testing without or with coronary artery calcium scoring (-/+ CAC) is non-inferior to treadmill ECG stress testing -/+ CAC and pharmacologic myocardial perfusion imaging as an initial evaluation to detect obstructive coronary artery disease, determined by cardiac computed tomographic angiography (CTA) and to predict clinical outcome, defined by a primary clinical endpoint of the composite of cardiovascular (CV) mortality, myocardial infarction, and 90-day post-stress test coronary artery revascularization and secondary clinical endpoints of all-cause mortality and CV mortality.

Condition or disease Intervention/treatment
Veterans Referred to the St. Louis VAMC Stress Tes Procedure: Regadenoson myocardial perfusion imaging stress test Procedure: Arm exercise electrocardiographic stress test Procedure: Treadmill electrocardiographic stress test Procedure: Coronary artery calcium score and cardiac computed tomographic angiography

Detailed Description:
Treadmill exercise capacity and other physiologic responses to leg exercise are powerful predictors of mortality and provide important clinical and diagnostic information. However, many Veterans cannot perform treadmill exercise because of lower extremity or other disabilities. For many years, pharmacologic myocardial perfusion imaging (MPI) has been the standard of care for their evaluation but fails to provide powerful prognostic and clinically relevant information of exercise testing, requires exposure to ionizing radiation, and is several times more expensive than exercise electrocardiography (ECG). With a recently completed Merit Review award, we obtained substantial retrospective observational evidence that arm exercise ECG stress testing scores are at least equivalent to pharmacologic MPI for robust prediction of mortality and other measures of clinical outcome in Veterans who cannot perform leg exercise. Major hypotheses for the current proposal are: 1) arm exercise ECG stress testing scores or best fit models without or with coronary artery calcium scoring (-/+ CACS) are non-inferior to the Duke Treadmill Score -/+ CACS, best fit model treadmill ECG and regadenoson (r) MPI stress testing, all performed in the same Veterans in randomized order, as an initial evaluation for obstructive coronary artery disease (oCAD), and 2) arm exercise ECG stress testing scores or best fit models -/+ CACS are non-inferior to the Duke Treadmill Score -/+ CACS, best fit model treadmill ECG and rMPI stress testing in the same Veterans for predicting the primary clinical endpoint (composite of cardiovascular (CV) mortality, myocardial infarction, or 90-day post-stress test coronary revascularization) and secondary clinical endpoints of all-cause mortality and CV mortality. Our specific aim for all Veterans referred to the St. Louis Veterans Administration (VA) stress testing laboratory and are without exclusions for exercise or regadenoson stress testing or cardiac computed tomographic angiography (CTA), is to perform a single site prospective clinical trial comparing arm exercise ECG stress test scores and best models -/+ CACS with the Duke Treadmill Score -/+ CACS if able to perform treadmill exercise, and best fit treadmill ECG and rMPI models, all performed in the same Veterans, for identification of the diagnostic endpoint of oCAD, defined as a severely ( 70%) occluded epicardial, graft, or 50% left main coronary artery lumen, determined by cardiac CTA or invasive coronary arteriography, and prediction of the primary and secondary clinical endpoints described above. The arm exercise scoring system to be evaluated incorporates the variables arm exercise capacity in resting metabolic equivalents, 1-minute heart rate recovery and arm exercise-induced ST depression of 1 mm or greater. Regadenoson MPI variables to be evaluated include an abnormal MPI study and best fit models of summed stress and difference scores, transient ischemic dilatation, gated left ventricular ejection fraction, and the heart rate response. We plan to enroll 75 Veterans per year for 4 years and follow the entire cohort for an additional year. Statistical analyses will be performed with SAS using univariate and multivariate logistic and Cox regression models. We will evaluate non-inferiority of arm exercise scores -/+ CACS for their association with oCAD and prediction of clinical endpoints with a non-inferiority margin of 0.05. A long term goal is to develop a multi-site prospective randomized VA Cooperative Study to assess generalizability of arm exercise ECG stress testing -/+ CACS for diagnostic and prognostic evaluation in the VA and United States healthcare systems.

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Arm Exercise Versus Pharmacologic Stress Testing for Clinical Outcome Prediction
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Regadenoson

Group/Cohort Intervention/treatment
St. Louis VA Healthcare System stress testing referrals
St. Louis VA Healthcare System cardiac stress testing laboratory referrals who are eligible and willing to complete an arm exercise ECG stress test, a treadmill ECG stress test if able, a regadenoson myocardial perfusion imaging stress test, and a coronary artery calcium score and cardiac computed tomographic angiography evaluation within 60 days if not referred for invasive coronary arteriography.
Procedure: Regadenoson myocardial perfusion imaging stress test
Best fit model of pharmacologic myocardial perfusion imaging data, including summed stress and difference scores, gated left ventricular ejection fraction, transient ischemic dilatation, and heart rate response to regadenoson data.
Other Name: Lexiscan

Procedure: Arm exercise electrocardiographic stress test
Published arm exercise score and best fit model of arm exercise ECG stress testing data.
Other Name: Arm exercise ECG

Procedure: Treadmill electrocardiographic stress test
Duke Treadmill Score and best fit model of treadmill exercise ECG stress testing data.
Other Name: Treadmill ECG

Procedure: Coronary artery calcium score and cardiac computed tomographic angiography
Coronary artery calcium score by Agatston criteria and severe obstructive coronary artery disease > 70% by cardiac computed tomographic angiography or invasive coronary arteriography.
Other Name: Coronary calcium score and cardiac CTA




Primary Outcome Measures :
  1. Composite of cardiovascular mortality, myocardial infarction, and 90-day post-stress test coronary artery revascularization [ Time Frame: 5 years ]
    Death from a cardiovascular cause, occurrence of myocardial infarction, and 90-day post-stress test coronary artery revascularization by any technique determined from VA, National Death Index, Missouri Health and Human Services, and non-VA medical records, and patient follow-up information.


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 5 years ]
    Death from any cause determined from VA, Social Security, and National Death Index records and patient follow-up information.

  2. Cardiovascular mortality [ Time Frame: 5 years ]
    Death from a cardiovascular cause determined from VA, Missouri Health and Human Services, and National Death Index records and patient follow-up information.


Other Outcome Measures:
  1. Obstructive coronary artery disease [ Time Frame: 5 years ]
    Severely (at least 70%) or completely occluded epicardial coronary arteries or grafts determined by cardiac computed tomographic angiography or invasive coronary arteriography



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Any veteran referred to the St. Louis VA Healthcare System stress testing laboratory
Criteria

Inclusion Criteria:

  • Any veteran referred to the St. Louis VA Healthcare System stress testing laboratory for a cardiac stress test

Exclusion Criteria:

  • Contra-indications to stress testing such as acute coronary syndrome, uncompensated heart failure, or unstable cardiac dysrhythmias Inability to perform arm exercise stress testing
  • Contra-indications to regadenoson stress testing such as significant reversible airway disease, heart block, or low blood pressure
  • An abnormal baseline ECG (e.g. left bundle branch block, widespread ST segment depression of at least 1 mm, ventricular paced rhythm) that precludes interpretation of the stress ECG
  • Contra-indications to cardiac computed tomographic angiography (CTA) such as contrast allergies and renal dysfunction (glomerular filtration rate < 30 ml/min)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03449888


Contacts
Contact: Wade H Martin, MD (314) 289-6329 wade.martin@va.gov

Locations
United States, Missouri
St. Louis VA Medical Center John Cochran Division, St. Louis, MO Recruiting
Saint Louis, Missouri, United States, 63106
Contact: Wade H Martin, MD    314-289-6329    wade.martin@va.gov   
Principal Investigator: Wade H. Martin, MD         
Sponsors and Collaborators
VA Office of Research and Development
VA St. Louis Health Care System
Investigators
Principal Investigator: Wade H. Martin, MD St. Louis VA Medical Center John Cochran Division, St. Louis, MO

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03449888     History of Changes
Other Study ID Numbers: CARA-008-17F
1 101 CX001345-01A3 ( Other Identifier: VA St. Louis Health Care System )
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Calcium, Dietary
Regadenoson
Bone Density Conservation Agents
Physiological Effects of Drugs
Adenosine A2 Receptor Agonists
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action