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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01134913
Recruitment Status : Completed
First Posted : June 2, 2010
Last Update Posted : August 31, 2012
Information provided by (Responsible Party):

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.

Condition or disease
Acute Coronary Syndrome

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.

Study Type : Observational
Actual Enrollment : 621 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multi-Markers In the Diagnosis of Acute Coronary Syndrome - Sample Procurement Cohort 3
Study Start Date : March 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : December 2011

Biospecimen Retention:   Samples Without DNA
EDTA Plasma Specimens

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting to the ED within 6 hours with symptoms consistent with ACS.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01134913

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Hospital
Boston, Massachusetts, United States, 02215
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