Study for Evaluation of Newly Onset Chest Pain and Rapid Diagnosis of Myocardial Necrosis (stenoCARDIA)
|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.|
|ClinicalTrials.gov Identifier: NCT03227159|
Recruitment Status : Completed
First Posted : July 24, 2017
Last Update Posted : July 24, 2017
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|
|Study Type :||Observational|
|Actual Enrollment :||1818 participants|
|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|
- 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
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
|Principal Investigator:||Stefan Blankenberg, MD||University Heart Center Hamburg|