Multi-Markers In the Diagnosis of Acute Coronary Syndrome (Midas 3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biosite
ClinicalTrials.gov Identifier:
NCT01134913
First received: May 29, 2010
Last updated: August 30, 2012
Last verified: August 2012
  Purpose

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.


Condition
Acute Coronary Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multi-Markers In the Diagnosis of Acute Coronary Syndrome - Sample Procurement Cohort 3

Further study details as provided by Biosite:

Biospecimen Retention:   Samples Without DNA

EDTA Plasma Specimens


Enrollment: 621
Study Start Date: March 2010
Study Completion Date: December 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Detailed Description:

This is a prospective, multi-center, observational, and sample procurement study of adult subjects presenting to an Emergency Department (ED) in whom ACS is in the differential diagnosis. Subjects must present to one of the participating EDs within 6 hours or less from the time of symptom onset, and must have experienced at least 5 minutes of chest discomfort.

Those ED patients with possible ACS who meet the inclusion/exclusion criteria will be approached for study enrollment by trained research personnel.

The patient's diagnostic work-up and treatment will continue per the standards of the treating institution. As indicated by their clinical presentation, it is anticipated that all patients in this study will have an electrocardiogram (ECG) upon admission to the ED and if the patient is found not to have an ST-elevation myocardial infarction (STEMI), objective cardiac testing will be conducted for evidence of MI. The Principal Investigator at each site will evaluate the results of the objective cardiac tests combined with biomarker evidence of myocardial necrosis to determine whether or not a patient enrolled at their site has a final diagnosis of ACS.

Cardiac events and procedure, such as angioplasty-stenting and coronary artery bypass surgery (CABG), will be recorded during the index ED visit, hospitalization and post-hospital follow-up period. Subjects will have a 30-day, 3 month and 6 month follow-up contact by phone or medical chart review to collect this information on cardiac events, procedures and survival.

Blood samples collected at several time points during the index ED visit will be used for future testing of novel blood markers as they become available.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  1. Patient is 18 years of age or older at time of enrollment.
  2. Patient presenting to the ED within 6 hours from the onset of symptoms consistent with ACS.
  3. Subject presented with at least one symptom outlined below:

    1. 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.
    2. Chest discomfort of shorter duration due to pharmacologic intervention.
    3. Ischemic Equivalent, Chest Pain Syndrome, Anginal Equivalent, or Ischemic ECG Abnormalities.
  4. Physician plans to perform objective cardiac testing as defined by the protocol in Section 3.2.

Exclusion Criteria:

  1. Patient (or Legal Representative) unable or unwilling to provide informed consent.
  2. Patient (or Legal Representative) refusal of telephone follow-up or medical record review at 30 days, 90 days and 180 days post-ED presentation.
  3. Patient (or Legal Representative) refusal for multiple blood sample collections over the study period.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01134913

Locations
United States, Massachusetts
Beth Israel Deaconess Hospital
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
New York Methodist Hospital
Brooklyn, New York, United States, 11215
SUNY Stony Brook
Stony Brook, New York, United States, 11794
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pennsylvania
Philidelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Biosite
  More Information

No publications provided by Biosite

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Biosite
ClinicalTrials.gov Identifier: NCT01134913     History of Changes
Other Study ID Numbers: BSTE-0101-1
Study First Received: May 29, 2010
Last Updated: August 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Biosite:
ACS
Acute Coronary Syndrome
Emergency Department

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014