Better Evaluation of Acute Chest Pain With Computed Tomography Angiography

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether cardiac CT can improve triage of acute chest pain patients in the emergency department.

Detailed Description
-----------------
Myocardial infarction remains one of the most important causes of death and disability. Therefore it is important that individuals with acute chest pain are accurately assessed without delaying appropriate treatment. Acute coronary syndrome is only one cause for sudden chest pain, which is a very common complaint in the ER. Other life threatening causes such as pulmonary embolism and aortic dissection may also be the cause, although most chest discomfort has a benign reason (musculoskeletal, hyperventilation, oesophageal reflux, etc). The current work-up of suspected acute coronary syndrome, based on presentation, symptoms, ECG and biomarkers, is not efficient and results in unnecessary diagnostics and hospital admissions, as well as errors or delayed diagnoses, in a substantial number of patients. Computed tomography angiography (CTA) images atherosclerosis, coronary obstruction as well as myocardial hypoperfusion. We hypothesize that early use of CTA is of incremental value and allows for accurate and immediate triage of patients with acute chest pain.

Official Title
-----------------
Better Evaluation of Acute Chest Pain With Computed Tomography Angiography - A Randomized Controlled Trial

Conditions
-----------------
Acute Coronary Syndrome, Acute Chest Pain

Intervention / Treatment
-----------------
* Radiation: Cardiac CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute chest pain or equivalent Patients older than 30 years Males < 75 years and Females < 80 years Exclusion Criteria: STEMI Troponin > 0.1 History of known myocardial infarction, PCI or CABG Pregnancy Contrast allergy Renal disfunction No informed consent possible No follow-up possible

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cardiac CT<br>Triage based on cardiac CT results. | Radiation: Cardiac CT<br>* Calcium scan and CT coronary angiography<br>|
| No Intervention: Standard Care<br>Standard diagnostic management according to the European guidelines. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful discharge rate | The proportion of patients discharged home without major adverse events during the following 30 days. Major adverse events are cardiovascular death or non-fatal myocardial infarction. | 30 days | 
| Diagnostic yield of invasive angiography | Number of patients identified with severe coronary artery disease identified by invasive angiography requiring revascularisation according to the international guidelines. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful discharge rate for all adverse events | The proportion of patients discharged home without any adverse events during the following 30 days. Adverse events are cardiovascular death, non-fatal myocardial infarction, unstable angina, coronary revascularization, repeat hospital visits for chest pain. | 30 days | 
| Major adverse events | Composite endpoint of major adverse cardiac events at 6 months: cardiovascular death, non-fatal myocardial infarction, unstable angina, coronary revascularisation and repeat hospital visits for chest pain. | 6 months | 
| Acute coronary syndrome | Diagnosis of acute coronary syndrome, according to international guidelines, at time of discharge. | Index hospital visit | 
| Missed myocardial infarctions | Missed myocardial infarctions, at 2-day follow-up, in patients discharged from the emergency department. | 2 days | 
| Duration of hospital stay | Duration of hospital stay | Index hospital visit | 
| Direct medical cost | Direct medical costs until 30th day after ED visit. | 30 days | 
| Radiation exposure | Cumulative medical radiation exposure at 6 months. | 6 months | 
| Renal function | Change in renal function after 2 days. | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute coronary syndrome