Stress-Delta Biomarkers for Acute Coronary Syndrome Risk Stratification

NCT02717702 | Completed

• 1 other identifier: Pro00056764
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (2)

• % Post Stress-Delta

  1-hour Post-Stress Troponin I - Resting Baseline Troponin I)/ Resting Baseline Troponin I

  1 hour

• % 2-hour Stress-Delta

  (3-hour Post-Stress Troponin I - Resting Baseline Troponin I)/ Resting Baseline Troponin I

  2 hour

Secondary Outcomes (2)

• Delta BNP values

  1hr

• Delta BNP values

  2hr

Study Arms (1)

ACS Patients

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential participants are patients presenting to the Emergency Department for evaluation of ACS.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Alexander T Limkakeng, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: March 24, 2016
• Study Start: August 10, 2016
• Primary Completion: May 7, 2018
• Study Completion: June 11, 2019
• Last Updated: August 19, 2019

Record last verified: 2019-08

Locations

US (1)