Ignite Creation Date:
2025-12-24 @ 2:34 PM
Ignite Modification Date:
2026-01-14 @ 3:50 AM
Study NCT ID:
NCT03227159
Status:
COMPLETED
Last Update Posted:
2017-07-24
First Post:
2017-07-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study for Evaluation of Newly Onset Chest Pain and Rapid Diagnosis of Myocardial Necrosis
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Organization:
Study Overview
Official Title:
Study for Evaluation of Newly Onset Chest Pain and Rapid Diagnosis of Myocardial Necrosis (stenoCARDIA)
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
stenoCARDIA
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: