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Stress-Delta Biomarkers for Acute Coronary Syndrome Risk Stratification

Abbott Stress-Delta Biomarkers for ACS Risk Stratification

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02717702
Enrollment
125
Registered
2016-03-24
Start date
2016-08-10
Completion date
2019-06-11
Last updated
2019-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

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.

Interventions

None listed

Sponsors

Duke University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
% Post Stress-Delta1 hour1-hour Post-Stress Troponin I - Resting Baseline Troponin I)/ Resting Baseline Troponin I
% 2-hour Stress-Delta2 hour(3-hour Post-Stress Troponin I - Resting Baseline Troponin I)/ Resting Baseline Troponin I

Secondary

MeasureTime frame
Delta BNP values1hr

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026