CArdiac cT in the Treatment of Acute CHest Pain 2 - Myocardial CT Perfusion (CATCH2)

Rigshospitalet

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Procedure: CTA guided treatment strategy; Procedure: CTA+CTP guided treatment strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT02014311

H-3-2013-065

Details and patient eligibility

About

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

Full 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.

Enrollment: 600 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 2 patient groups

CTA+CTP guided treatment strategy

Experimental group

Description:

Patients with adenosine stress induced regional myocardial hypoperfusion (CT perfusion imaging) in combination with a corresponding epicardial coronary vessel with \>50% stenosis (Coronary CT angiography) will be referred for invasive investigation within 30 days after study inclusion - CTP-INTERVENTION

Treatment:

Procedure: CTA+CTP guided treatment strategy

CTA guided treatment strategy

Active Comparator group

Description:

Patients with at least one epicardial coronary artery stenosis \>50% (Coronary CT angiography) will be referred for invasive investigation within 30 days after initial discharge from the hospital - CONTROL

Treatment:

Procedure: CTA guided treatment strategy