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

NCT02014311 | Completed

• 1 other identifier: H-3-2013-065
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 7

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

Conditions

Coronary Artery Disease

Keywords

Multidetector Computed Tomography; Myocardial Perfusion Imaging; Coronary Stenosis; Coronary Artery Disease; Angina Pectoris

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

CTA+CTP guided treatment strategy

EXPERIMENTAL

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

Procedure: CTA+CTP guided treatment strategy

CTA guided treatment strategy

ACTIVE COMPARATOR

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

Procedure: CTA guided treatment strategy

Interventions

CTA+CTP guided treatment strategy PROCEDURE

CTA+CTP guided treatment strategy

CTA+CTP guided treatment strategy

CTA guided treatment strategy PROCEDURE

CTA guided treatment strategy

CTA guided treatment strategy

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recent acute-onset chest pain where coronary artery disease is suspected
• During initial acute hospitalization:
• Normal coronary biomarkers (Troponins)
• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Copenhagen University Hospital, Hvidovre: collaborator
• Amager Hospital: collaborator
• Bispebjerg Hospital: collaborator
• Herlev Hospital: collaborator
• Glostrup University Hospital, Copenhagen: collaborator
• University Hospital, Gentofte, Copenhagen: collaborator

Study Sites (7)

Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen

Copenhagen, 2100, Denmark

Location

Department of Cardiology, Amager University Hospital

Copenhagen, Denmark

Location

Department of Cardiology, Bispebjerg University Hospital

Copenhagen, Denmark

Location

Department of Cardiology, Gentofte University Hospital

Copenhagen, Denmark

Location

Department of Cardiology, Glostrup University Hospital

Copenhagen, Denmark

Location

Department of Cardiology, Herlev Hospital

Copenhagen, Denmark

Location

Department of Cardiology, Hvidovre University Hospital

Copenhagen, Denmark

Location

Related Publications (2)

• 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.

  PMID: 23998546 BACKGROUND

• 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.

  PMID: 22143171 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis; Angina Pectoris

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Klaus F Kofoed, MD, DmSc

  Department of Cardiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: December 18, 2013
• Study Start: October 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: December 1, 2022
• Last Updated: December 12, 2022

Record last verified: 2022-12

Locations

DK (7)