Cardiac-CT in the Treatment of Acute Chest Pain

Study Overview
=================
Brief Summary
-----------------
Objectives The CATCH trial (CArdiac cT in the treatment of acute CHest pain) is a prospective randomized controlled trial designed to evaluate the clinical value of cardiac multidetector computed tomography (MDCT) as a first-line diagnostic strategy in patients with acute chest pain, compared to a conventional functional-based testing strategy. Methods: Consecutive patients admitted with acute chest pain of suspected cardiac origin, but normal electrocardiogram and biomarkers were randomized to evaluation with 320-MDCT coronary angiography (CT-guided group) or with standard bicycle exercise test and/or myocardial perfusion imaging - MPI (Control group). After one year, patients will be followed-up, with registration of clinical endpoints such as Cardiac death, myocardial infarction, need for revascularisation, admittance for heart related problems, sustained chest pain, live quality score, use of medication.

Official Title
-----------------
Cardiac-CT in the Treatment of Acute Chest Pain

Conditions
-----------------
Ischemic Heart Disease

Intervention / Treatment
-----------------
* Procedure: Cardiac computed tomographic angiography (CCTA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admittance because of Chest pain Non- or non-diagnostic ecg-changes. Normal biomarkers for ischemia (Troponins) Chest X-ray without pathological findings associated with chest pain. Exclusion Criteria: Women of childbearing age, or > 40 years and using approved contraception. Claustrophobia Patients with geographical residence, that complicates follow-up Patients with mental or physical conditions that impede follow-up Increase in Troponins New diagnostic ECG changes with ST-segment elevation or depression greater than 1mm or T-yew inversion> 4 mm in> 2 anatomically connected derivations. Allergy to iodinated contrast agents Serum creatinine greater than 130 mg/l Abnormal chest x-ray or blood tests hospitalization as assessed as the main cause of the patient's pain problem.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: CT guided group<br>For Patients with chest pain randomised to this arm, clinical decision will be based on the results of a Cardiac computed tomographic angiography (CCTA) | Procedure: Cardiac computed tomographic angiography (CCTA)<br>* Patients will (on top of the standard clinical evaluation with a functional-based stress-test) be examined with a Cardiac CT scan. In the control group, the Cardiac CT will be blinded for clinical evaluation and only used retrospectively for research purpose.<br>* Other names: Adenosin for CT myocardial perfusion;|
| No Intervention: Control group<br>Patients with chest pain randomised to the control group will be evaluated using the standard functional-based strategy with either a treadmill stress-test or SPECT (single-photon emission computed tomography). A Cardiac CT will will be performed, but will be blinded for initial clinical evaluation. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| combined endpoint of: Cardiac death, myocardial infarction, unstabile angina, revascularisation, readmissions for chest pain |  | 1 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac death |  | 1 year follow-up | 
| myocardial infarction |  | 1 year follow-up | 
| readmissions for chest pain |  | 1 year follow-up | 
| Revascularisation |  | 1 year follow-up | 
| unstabile angina |  | 1-year follow-up | 
| continued chest pain |  | 1 year follow-up | 
| Quality of life (SF-36) |  | 1-year follow-up | 
| medication |  | 1-year follow-up | 
| non-cardiac findings on CT |  | 1-year follow-up | 
| downstream testing |  | 1-year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac CT, Ischemic heat disease, Stress test