Clinical trial NCT02014311: CArdiac cT in the Treatment of Acute CHest Pain 2 - Myocardial CT Perfusion
Official title: Myocardial Perfusion 320 MDCT Guided Treatment Strategy for the Clinical Management of Patient With Recent Acute-onset Chest Pain. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Multidetector Computed Tomography
Myocardial Perfusion Imaging
Coronary Stenosis
Coronary Artery Disease
Angina Pectoris
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Copenhagen University Hospital, Hvidovre
name: Amager Hospital
name: Bispebjerg Hospital
name: Herlev Hospital
name: Glostrup University Hospital, Copenhagen
name: University Hospital, Gentofte, Copenhagen
First posted: 2013-12-18
Enrollment: 600
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to assess whether the clinical management of patients with recent acute-onset chest pain without acute coronary syndrome may be optimized by a combined coronary CT angiography (CTA) + CT myocardial perfusion (CTP) guided, rapid diagnostic strategy as compared to CTA alone. CT diagnostic evaluation and potential referral for invasive testing will be performed within 2 weeks after hospital discharge.

The following main hypothesis will be tested:

- Combined assessment of coronary anatomy and myocardial perfusion using 320 MDCT results in a safe and optimized, cost-effective invasive treatment strategy

Detailed description: MATERIAL

- Consecutive patients referred with chest pain in whom acute coronary syndrome has been excluded, yet with a maintained clinical suspicion of coronary artery disease will be included in the study. Only patients deemed clinically suited for subsequent invasive evaluation and treatment will be included.

METHODS

-If the patients accept participation in the trial a computerized 1:1 randomization for CTA alone (control group) or CTA and CTP combined (intervention group) within 2 weeks from discharge will be conducted. CT angiography and CT myocardial perfusion imaging will be performed using a 320-slice MSCT Toshiba VISION Edition Aquilion One scanner according to recommendations from the vendor and clinical routine developed at Rigshospitalet. Based on CTA and/or CTP findings patients will be referred for invasive evaluation including fractional flow reserve assessment (FFR) and treatment within 30 days. Invasive procedures will be performed according to international guidelines and the frequency of revascularization procedures recorded. Clinical outcome data according to specified secondary endpoints will be recorded from hospital charts and medical registries.

Eligibility criteria: Inclusion Criteria:

* Recent acute-onset chest pain where coronary artery disease is suspected
* During initial acute hospitalization:

  1. Normal coronary biomarkers (Troponins)
  2. No or non-diagnostic ECG changes (LV hypertrophy, bundle branch blok, pacemaker rhythm)
* Age ≥50 years
* ≥ 1 cardiovascular risk factor (family history of CAD, hypertension, hypercholesterolemia, diabetes, smoking) corresponding to a Duke clinical score ≥20%

Exclusion Criteria:

* Known Iodine contrast allergy
* Estimated GFR below 50 ml/min
* Adenosine intolerance - known allergic asthma
* Previous CABG
* Patient related circumstances which preclude informed consent from the patient
* Patients in whom psychiatric, physical or geographic conditions do not allow long-term clinical followup
* Expected survival of less that 2 years

Primary outcomes:
measure: Frequency of coronary revascularization among included patients referred for invasive investigation
timeFrame: Within 60 days of study inclusion
Secondary outcomes:
measure: Hospital admittance due to recurrence of chest pain, acute myocardial infarction or cardiac death
timeFrame: Within 3, 12 and 24 months after CT examination
measure: New referral for invasive investigation following inititial evaluation
timeFrame: 3, 12 and 24 months after CT examination
measure: Coronary revascularization - not including revascularization related to index evaluation
timeFrame: 3, 12 and 24 months after CT examination
measure: Invasive procedure related events
timeFrame: Within 30 days of invasive procedure
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
city: Copenhagen
country: Denmark
facility: Department of Cardiology, Amager University Hospital
city: Copenhagen
country: Denmark
facility: Department of Cardiology, Bispebjerg University Hospital
city: Copenhagen
country: Denmark
facility: Department of Cardiology, Gentofte University Hospital
city: Copenhagen
country: Denmark
facility: Department of Cardiology, Glostrup University Hospital
city: Copenhagen
country: Denmark
facility: Department of Cardiology, Herlev Hospital
city: Copenhagen
country: Denmark
facility: Department of Cardiology, Hvidovre University Hospital
Study officials:
affiliation: Department of Cardiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen, Denmark
name: Klaus F Kofoed, MD, DmSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Linde JJ, Kofoed KF, Sorgaard M, Kelbaek H, Jensen GB, Nielsen WB, Hove JD. Cardiac computed tomography guided treatment strategy in patients with recent acute-onset chest pain: results from the randomised, controlled trial: CArdiac cT in the treatment of acute CHest pain (CATCH). Int J Cardiol. 2013 Oct 15;168(6):5257-62. doi: 10.1016/j.ijcard.2013.08.020. Epub 2013 Aug 14.
citation: Kuhl JT, Linde JJ, Fuchs A, Kristensen TS, Kelbaek H, George RT, Hove JD, Kofoed KF. Patterns of myocardial perfusion in humans evaluated with contrast-enhanced 320 multidetector computed tomography. Int J Cardiovasc Imaging. 2012 Oct;28(7):1739-47. doi: 10.1007/s10554-011-9986-z. Epub 2011 Dec 6.