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

Coronary Artery Disease Clinical Trial

— CATCH2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02014311
• Other study ID #: H-3-2013-065
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: December 2022

Study information

• Verified date: December 2022
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 2022
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chest Pain
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• CTA+CTP guided treatment strategy
CTA+CTP guided treatment strategy
• CTA guided treatment strategy
CTA guided treatment strategy

Locations

Country	Name	City	State
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, Herlev Hospital	Copenhagen
Denmark	Department of Cardiology, Hvidovre University Hospital	Copenhagen

Sponsors (7)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Amager Hospital, Bispebjerg Hospital, Copenhagen University Hospital, Hvidovre, Glostrup University Hospital, Copenhagen, Herlev Hospital, University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of coronary revascularization among included patients referred for invasive investigation	Among patients referred for invasive coronary evaluation the frequency of subsequent PCI and/or CABG is recorded	Within 60 days of study inclusion
Secondary	Hospital admittance due to recurrence of chest pain, acute myocardial infarction or cardiac death		Within 3, 12 and 24 months after CT examination
Secondary	New referral for invasive investigation following inititial evaluation		3, 12 and 24 months after CT examination
Secondary	Coronary revascularization - not including revascularization related to index evaluation		3, 12 and 24 months after CT examination
Secondary	Invasive procedure related events	Among patients referred for invasive evaluation and treatment, procedure related events including death, bleeding, vascular complications, stroke and acute myocardial infarction will be recorded	Within 30 days of invasive procedure