Stress-Delta Biomarkers for Acute Coronary Syndrome Risk Stratification



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:40 - Any
Updated:8/2/2018
Start Date:August 10, 2016
End Date:May 2019

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Abbott Stress-Delta Biomarkers for ACS Risk Stratification

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.


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.
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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