Ignite Creation Date:
2024-05-06 @ 3:59 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02422316
Status:
COMPLETED
Last Update Posted:
2016-02-17
First Post:
2015-04-16
Brief Title:
Non-contrast Cardiac CT as a Risk Stratification Tool in Patients With Non-cardiac Chest Pain
Sponsor:
University of Southern Denmark
Organization:
University of Southern Denmark
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2016-02
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:
None
Brief Summary:
Background
Only around 20 of all patients seen in hospital with suspected Acute Coronary Syndrome will have Acute Myocardial Infarction However several studies indicate that patients where ACS had been excluded by conventional methods sustain a higher cardiac morbidity and mortality than the background population Not all of these patients can be identified by traditional risk factors such as cholesterol hypertension and diabetes or with conventional methods such as ECG troponin and clinical symptoms Non-Contrast Cardiac-CT measures the amount of calcification in the coronary arteries and might be a useful addition in predicting future cardiac events in this patient group The aim of this study is through a double-blinded study to determine whether non-contrast CT scan with calcium score can be used to identify patients at increased risk of death and cardiac event within the following 12 months after an acute admission where troponin measurements were normal
Methods
The study will investigate patients with suspected Acute Coronary syndrome who have been examined and subsequently sent home from an emergency- or cardiology department without ACS or another obvious explanation 750 patients age 30-70 years who are included in the study Identification of risk factors in non-cardiac chest pain patients will be offered a non-contrast CT scan with calcium score within 14 days after the hospital contact The participants will be included in a 12 months follow up where the result of the calcium score is not revealed neither for the patient nor the investigator After 12 months the results of the scan is compared with the rate of cardiac events This project is a multicenter study and recruits patients from 6 emergency - and cardiology departments in the region of Southern Denmark
The study commences at September 2014 and results of this project are expected to contribute to the risk stratification of Non-cardiac chest pain patients
Only around 20 of all patients seen in hospital with suspected Acute Coronary Syndrome will have Acute Myocardial Infarction However several studies indicate that patients where ACS had been excluded by conventional methods sustain a higher cardiac morbidity and mortality than the background population Not all of these patients can be identified by traditional risk factors such as cholesterol hypertension and diabetes or with conventional methods such as ECG troponin and clinical symptoms Non-Contrast Cardiac-CT measures the amount of calcification in the coronary arteries and might be a useful addition in predicting future cardiac events in this patient group The aim of this study is through a double-blinded study to determine whether non-contrast CT scan with calcium score can be used to identify patients at increased risk of death and cardiac event within the following 12 months after an acute admission where troponin measurements were normal
Methods
The study will investigate patients with suspected Acute Coronary syndrome who have been examined and subsequently sent home from an emergency- or cardiology department without ACS or another obvious explanation 750 patients age 30-70 years who are included in the study Identification of risk factors in non-cardiac chest pain patients will be offered a non-contrast CT scan with calcium score within 14 days after the hospital contact The participants will be included in a 12 months follow up where the result of the calcium score is not revealed neither for the patient nor the investigator After 12 months the results of the scan is compared with the rate of cardiac events This project is a multicenter study and recruits patients from 6 emergency - and cardiology departments in the region of Southern Denmark
The study commences at September 2014 and results of this project are expected to contribute to the risk stratification of Non-cardiac chest pain patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None