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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Procedure: CTA+CTP guided treatment strategy; Procedure: CTA guided treatment strategy

• Registration Number: NCT02014311
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-12-12
• Study First Submitted QC: 2013-12-17
• Study First Posted: 2013-12-18
• Primary Completion: 2017-03
• Status Verified: 2022-12
• Study Completion: 2022-12
• Last Update Submitted: 2022-12-09
• Last Update Posted: 2022-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CTA+CTP guided treatment strategy	CTA+CTP guided treatment strategy	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
CTA guided treatment strategy	CTA guided treatment strategy	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

Primary Outcome Measures

Name	Time	Method
Frequency of coronary revascularization among included patients referred for invasive investigation	Within 60 days of study inclusion	Among patients referred for invasive coronary evaluation the frequency of subsequent PCI and/or CABG is recorded

Secondary Outcome Measures

Name	Time	Method
Hospital admittance due to recurrence of chest pain, acute myocardial infarction or cardiac death	Within 3, 12 and 24 months after CT examination
New referral for invasive investigation following inititial evaluation	3, 12 and 24 months after CT examination
Coronary revascularization - not including revascularization related to index evaluation	3, 12 and 24 months after CT examination
Invasive procedure related events	Within 30 days of invasive procedure	Among patients referred for invasive evaluation and treatment, procedure related events including death, bleeding, vascular complications, stroke and acute myocardial infarction will be recorded

Trial Locations

Locations (7)

Department of Cardiology, Herlev Hospital; 🇩🇰 Copenhagen, Denmark

Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen; 🇩🇰 Copenhagen, Denmark

Department of Cardiology, Amager University Hospital; 🇩🇰 Copenhagen, Denmark

Department of Cardiology, Bispebjerg University Hospital; 🇩🇰 Copenhagen, Denmark

Department of Cardiology, Gentofte University Hospital; 🇩🇰 Copenhagen, Denmark

Department of Cardiology, Glostrup University Hospital; 🇩🇰 Copenhagen, Denmark

Department of Cardiology, Hvidovre University Hospital; 🇩🇰 Copenhagen, Denmark