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Stress-Delta Biomarkers for Acute Coronary Syndrome Risk Stratification

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02717702
Recruitment Status : Completed
First Posted : March 24, 2016
Last Update Posted : August 19, 2019
Information provided by (Responsible Party):
Duke University

Brief Summary:

Acute Coronary Syndrome (ACS) is a serious heart condition that is a leading cause of death in America. Cardiac stress testing is currently the best test to non-invasively identify which patients might be having ACS and may need more invasive testing such as a cardiac catheterization (placing a tube in the heart) for coronary angiogram (invasive mapping of the blood vessels of the heart). However, stress tests require imaging by highly trained specialists and even then may not correctly categorize a small minority of patients being evaluated for ACS.

Advances in blood tests may now allow detection of the very early stages of heart blood vessel blockage via a simple blood test. The investigators seek to determine whether these blood tests can help to better identify patients with ACS. The study will also store any extra blood sample that may be left over for future use.

Condition or disease
Acute Coronary Syndrome

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Study Type : Observational
Actual Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Abbott Stress-Delta Biomarkers for ACS Risk Stratification
Actual Study Start Date : August 10, 2016
Actual Primary Completion Date : May 7, 2018
Actual Study Completion Date : June 11, 2019

ACS Patients
Subjects will be patients presenting to the Emergency Department for evaluation of ACS.

Primary Outcome Measures :
  1. % Post Stress-Delta [ Time Frame: 1 hour ]
    1-hour Post-Stress Troponin I - Resting Baseline Troponin I)/ Resting Baseline Troponin I

  2. % 2-hour Stress-Delta [ Time Frame: 2 hour ]
    (3-hour Post-Stress Troponin I - Resting Baseline Troponin I)/ Resting Baseline Troponin I

Secondary Outcome Measures :
  1. Delta BNP values [ Time Frame: 1hr ]
  2. Delta BNP values [ Time Frame: 2hr ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Potential participants are patients presenting to the Emergency Department for evaluation of ACS.

Inclusion Criteria:

  • Any patient presenting to the ED with clinical suspicion of ACS as determined by the treating emergency physician. These include symptoms including but not limited to chest pain, pressure, or burning sensation across the precordium.
  • Age 40 years or older.
  • As part of their usual clinical care, the subject is scheduled to have a cardiac stress test. This includes nuclear (adenosine, regadenosine, or other adjunct with SPECT), either pharmacologic (dobutamine) or exercise (treadmill) echocardiography, or cardiac magnetic resonance imaging. Prior cardiac testing or observation unit evaluation is not an exclusion criterion.

Exclusion Criteria:

  • Patient with cardiac marker diagnosis of acute myocardial infarction or who otherwise is not a candidate for a cardiac stress test.
  • Evidence of serious arrhythmias or acute MI or ischemia on ECG
  • Unstable vital signs: persistent (> 2 readings or over 2 hours) hypotension (systolic blood pressure < 80 mm Hg), pulse > 110 beats per minute.
  • Any medical condition that would be worsened by cardiac stress
  • Aortic aneurysm or dissection
  • Active myocarditis or pericarditis
  • Ventricular dysrhythmia or significant atrial dysrhythmia
  • Severe or greater degree of aortic stenosis
  • Acute or decompensated heart failure or pulmonary edema
  • Pulmonary embolism
  • Aortic aneurysm
  • Patient is non-English speaking.
  • Patient is incarcerated or a prisoner.
  • Patient does not have capacity to consent.

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 identifier (NCT number): NCT02717702

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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
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Principal Investigator: Alexander T Limkakeng, MD Duke University
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Responsible Party: Duke University Identifier: NCT02717702    
Other Study ID Numbers: Pro00056764
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases