Multi-Markers In the Diagnosis of Acute Coronary Syndrome

Completed

Conditions studied: Acute Coronary Syndrome

In brief

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.

Key facts

Study ID

NCT01134913

Run by

Abbott RDx Cardiometabolic

People needed

621

Starts

2010-03-01

Expected to finish

2011-12-01

Last updated by the study team

2012-08-31

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Hospital — Boston, Massachusetts, United States
• New York Methodist Hospital — Brooklyn, New York, United States
• SUNY Stony Brook — Stony Brook, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• University of Pennsylvania — Philidelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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