Clinical trial NCT01534000: Cardiac-CT in the Treatment of Acute Chest Pain
Official title: Cardiac-CT in the Treatment of Acute Chest Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Heart Disease
Keywords: Cardiac CT
Ischemic heat disease
Stress test
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2012-02-16
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: combined endpoint of: Cardiac death, myocardial infarction, unstabile angina, revascularisation, readmissions for chest pain
timeFrame: 1 year follow-up
Secondary outcomes:
measure: Cardiac death
timeFrame: 1 year follow-up
measure: myocardial infarction
timeFrame: 1 year follow-up
measure: readmissions for chest pain
timeFrame: 1 year follow-up
measure: Revascularisation
timeFrame: 1 year follow-up
measure: unstabile angina
timeFrame: 1-year follow-up
measure: continued chest pain
timeFrame: 1 year follow-up
measure: Quality of life (SF-36)
timeFrame: 1-year follow-up
measure: medication
timeFrame: 1-year follow-up
measure: non-cardiac findings on CT
timeFrame: 1-year follow-up
measure: downstream testing
timeFrame: 1-year follow-up
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Jesper J Linde, MD
role: STUDY_DIRECTOR
References:
citation: Linde JJ, Hove JD, Sorgaard M, Kelbaek H, Jensen GB, Kuhl JT, Hindso L, Kober L, Nielsen WB, Kofoed KF. Long-Term Clinical Impact of Coronary CT Angiography in Patients With Recent Acute-Onset Chest Pain: The Randomized Controlled CATCH Trial. JACC Cardiovasc Imaging. 2015 Dec;8(12):1404-1413. doi: 10.1016/j.jcmg.2015.07.015. Epub 2015 Nov 11.