Multi-Markers In the Diagnosis of Acute Coronary Syndrome

NCT01134913 | Completed

• 1 other identifier: BSTE-0101-1
• Study Type: observational
• Target: 621
• Locations: 1 country
• Sites: 6

Brief Summary

This is a prospective clinical study designed to procure blood samples from patients who present to the Emergency Department with suspected ACS (Acute Coronary Syndrome). Subjects enrolled in this study will sign and informed consent and have 4 blood samples drawn at different time points during their emergency department visit. In addition, data will be collected about the patient's health history, hospital procedures, and final diagnosis. The enrolling center will also contact the patients at 30-days, 3 months and 6 months to inquire about their condition and survival. Blood samples collected in this study will be sent to the sponsor organization for long-term storage and analysis in the future for novel blood markers as they become available. No genetic testing will be conducted on these samples.

Conditions

Acute Coronary Syndrome

Keywords

ACS; Acute Coronary Syndrome; Emergency Department

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the ED within 6 hours with symptoms consistent with ACS.

You may qualify if:

• Patient is 18 years of age or older at time of enrollment.
• Patient presenting to the ED within 6 hours from the onset of symptoms consistent with ACS.
• Subject presented with at least one symptom outlined below:
• Chest discomfort of at least 5 minutes duration from time of symptom onset. Episodic or stuttering chest discomfort is acceptable if last episode preceding the ED presentation is within 6 hours of symptom onset.
• Chest discomfort of shorter duration due to pharmacologic intervention.
• Ischemic Equivalent, Chest Pain Syndrome, Anginal Equivalent, or Ischemic ECG Abnormalities.
• Physician plans to perform objective cardiac testing as defined by the protocol in Section 3.2.

You may not qualify if:

• Patient (or Legal Representative) unable or unwilling to provide informed consent.
• Patient (or Legal Representative) refusal of telephone follow-up or medical record review at 30 days, 90 days and 180 days post-ED presentation.
• Patient (or Legal Representative) refusal for multiple blood sample collections over the study period.

Sponsors & Collaborators

• Abbott RDx Cardiometabolic: lead

Study Sites (6)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Hospital

Boston, Massachusetts, 02215, United States

Location

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

SUNY Stony Brook

Stony Brook, New York, 11794, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philidelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• Smith SW, Diercks DB, Nagurney JT, Hollander JE, Miller CD, Schrock JW, Singer AJ, Apple FS, McCullough PA, Ruff CT, Sesma A Jr, Peacock WF. Central versus local adjudication of myocardial infarction in a cardiac biomarker trial. Am Heart J. 2013 Mar;165(3):273-279.e1. doi: 10.1016/j.ahj.2012.12.012. Epub 2013 Jan 26.

  PMID: 23453092 DERIVED

• Peacock WF, Nagurney J, Birkhahn R, Singer A, Shapiro N, Hollander J, Glynn T, Nowak R, Safdar B, Miller C, Peberdy M, Counselman F, Chandra A, Kosowsky J, Neuenschwander J, Schrock J, Plantholt S, Lewandrowski E, Wong V, Kupfer K, Diercks D. Myeloperoxidase in the diagnosis of acute coronary syndromes: the importance of spectrum. Am Heart J. 2011 Nov;162(5):893-9. doi: 10.1016/j.ahj.2011.08.017.

  PMID: 22093206 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

EDTA Plasma Specimens

MeSH Terms

Conditions

Acute Coronary Syndrome; Emergencies

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: May 29, 2010
• First Posted: June 2, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: December 1, 2011
• Last Updated: August 31, 2012

Record last verified: 2012-08

Locations

US (6)