Stress-Delta Biomarkers for Acute Coronary Syndrome Risk Stratification

Acute Coronary Syndrome Clinical Trial

Official title:

Abbott Stress-Delta Biomarkers for ACS Risk Stratification

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02717702
• Other study ID #: Pro00056764
• Status: Completed
• Start date: August 10, 2016
• Est. completion date: June 11, 2019

Study information

• Verified date: August 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: June 11, 2019
• Est. primary completion date: May 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% Post Stress-Delta	1-hour Post-Stress Troponin I - Resting Baseline Troponin I)/ Resting Baseline Troponin I	1 hour
Primary	% 2-hour Stress-Delta	(3-hour Post-Stress Troponin I - Resting Baseline Troponin I)/ Resting Baseline Troponin I	2 hour
Secondary	Delta BNP values		1hr
Secondary	Delta BNP values		2hr