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

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.

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Key information

Conditions

Acute Myocardial Infarction Disease Attributes Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Acronym: stenoCARDIA

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Jul 24, 2017
Registry last updated: Jul 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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