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Study for Evaluation of Newly Onset Chest Pain and Rapid Diagnosis of Myocardial Necrosis (stenoCARDIA)

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ClinicalTrials.gov Identifier: NCT03227159
Recruitment Status : Completed
First Posted : July 24, 2017
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Brief Summary:

This is a national multi-center, prospective surveillance study in patients with suspected acute coronary syndrome. Eligible patients must present to one of the participating Emergency Departments within 24 hours from the time of symptom onset. Approximately 2000 patients >18 and <85 years of age are planned to be enrolled.

Upon enrollment in the Emergency Department, a venous blood sample will be obtained from each patient for analysis. The patient's diagnostic work-up, treatment and disposition will continue per the standards of the treating institution. Results will be recorded for ECGs, any cardiac biomarkers measured at the site and any follow-up cardiac objective tests performed for evidence of coronary artery disease and/or myocardial damage (exercise treadmill, coronary angiography, cardiac thallium or technetium scintigraphy, etc).

The Principal Investigator at each site will evaluate the results of the diagnostic cardiac tests performed for that patient to determine whether each patient enrolled at their site has a final diagnosis of ACS.

The status of each patient will also be assessed at 1 month and 6 months after enrollment for intercurrent Major Adverse Cardiac Events (MACE), including myocardial infarction, cardiac revascularization and death.


Condition or disease
Acute Myocardial Infarction

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Study Type : Observational
Actual Enrollment : 1818 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study for Evaluation of Newly Onset Chest Pain and Rapid Diagnosis of Myocardial Necrosis (stenoCARDIA)
Actual Study Start Date : January 1, 2007
Actual Primary Completion Date : December 31, 2008
Actual Study Completion Date : December 31, 2008

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Diagnosis of acute coronary syndromes [ Time Frame: 30 days ]
    The primary end-point of the study is the early diagnosis of acute coronary syndromes using a combined analysis of multiple markers compared to single marker analyses (final diagnosis of ACS as reason for hospital admission).


Biospecimen Retention:   Samples With DNA
  • A venous blood sample (10 ml EDTA, 10ml Citrate, 10ml Serum) for storage and further analysis
  • A venous blood sample (10 ml EDTA ) DNA Analysis


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will focus on patients presenting to the ED within 24 hours of the onset of chest pain. Both patients then discharged to home as well as patients subsequently admitted to the hospital are eligible for the study and may be enrolled.
Criteria

Inclusion Criteria:

  • Only patients who are able to give consent. This has to be carefully verified in each case, by the doctors leading the study
  • Men or women >18 and <85 years of age
  • Patients with chest discomfort within last 24h and suspected Acute Coronary Syndrome (STEMI, NSTEMI and unstable angina)
  • Patient experiencing at least 30 minutes of chest discomfort or other symptoms consistent with possible ACS; (Note: Patients who have symptoms of shorter duration that resolved due to pharmacologic intervention may be included.)
  • Written informed consent

Exclusion Criteria:

  • Age <18 or >85 years
  • Inpatient in the hospital prior to onset of symptoms.
  • Obvious traumatic disease
  • Prisoners or other institutionalized or vulnerable individuals
  • Major surgery within last 4 weeks
  • Patients with cardiogenic shock
  • Other significant laboratory abnormalities that the investigator feels may compromise the patient's safety by participation in the study
  • Women who are pregnant or breast feeding
  • Obvious iv drug abuse
  • Refusal to provide written informed consent
  • Unavailability of a telephone number and insufficient contact information as well as permanent residence abroad
  • Unreliability as a study participant as based on the investigator's prior knowledge of the patient, such as the inability or willingness to participate in or complete the study or the presence of concurrent physical or psychological disorders that may make it impractical for the patient to participate in or complete the study

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 ClinicalTrials.gov identifier (NCT number): NCT03227159


Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
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Principal Investigator: Stefan Blankenberg, MD University Heart Center Hamburg

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03227159     History of Changes
Other Study ID Numbers: 837.075.06
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Acute Myocardial Infarction
Troponin
Emergency department

Additional relevant MeSH terms:
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Infarction
Myocardial Infarction
Necrosis
Chest Pain
Ischemia
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pain
Neurologic Manifestations
Signs and Symptoms