Evaluation of Spectral Cardiac CT for the Diagnosis of Acute Myocarditis (MYOCARDITESCAN)
Primary Purpose
Patients With Suspected Acute Myocarditis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Spectral cardiac CT scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Patients With Suspected Acute Myocarditis
Eligibility Criteria
Inclusion Criteria:
- Patients aged at least 18 years
- Patient having had a preliminary clinical examination:
eligible patients must present an increased level of troponin I (>laboratory threshold) associated with at least one of the 3 following criteria: i) prolonged chest pain > 10 minutes; ii) recent viral infectious illness <7 days; iii) patients without any history of coronary disease and/or free of cardiovascular risk factors
- Patient's written informed consent.
Exclusion Criteria:
- Iodine contrast allergy
- Severe renal impairment (GFR < 45 ml/min)
- Patient status: insufficient patient cooperation or dyspnea or hemodynamic instability with inability to hold a 8-10 seconds breath hold
- Pregnant women
- History of coronary artery disease
- Contra indications to MRI
- Patient under guardianship or trusteeship
- Non affiliation to social security or CMU (beneficiary or assignee)
Sites / Locations
- Bichat Claude Bernard HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Spectral cardiac CT scan
Arm Description
All patients will undergo cardiac CT scan with spectral mode acquisition
Outcomes
Primary Outcome Measures
Diagnosis of acute myocarditis using spectral cardiac CT scan
The test under study is the spectral cardiac CT scan. Diagnosis of acute myocarditis using spectral cardiac CT scan will be based on the presence of a contrast enhancement involving the subepicardial layers of the myocardial.
Secondary Outcome Measures
Radiation dose delivered in spectral cardiac CT scan
The radiation dose delivered in spectral cardiac CT scan using the latest generation of machines from different manufacturers (GE Healthcare and Siemens)
Full Information
NCT ID
NCT02905721
First Posted
September 7, 2016
Last Updated
July 5, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT02905721
Brief Title
Evaluation of Spectral Cardiac CT for the Diagnosis of Acute Myocarditis
Acronym
MYOCARDITESCAN
Official Title
Evaluation of Spectral Cardiac CT for the Diagnosis of Acute Myocarditis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 11, 2017 (Actual)
Primary Completion Date
October 10, 2022 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Spectral cardiac CT scan performed in an emergency setting in patients with suspected acute myocarditis and presenting one selves with an acute chest pain, allows the non-invasive assessment of both the coronary arteries and the myocardium. Delayed iodine contrast-enhanced CT imaging should show the inflamed area with an increased uptake of iodine contrast agent in the interstitial space, such as the well-known hypersignal seen on the myocardial delayed enhancement sequence with MRI (corresponding of an uptake of gadolinium contrast agent in the abnormal myocardium).
This technique has the potential to replace MRI, thus allowing the diagnosis of acute myocarditis with a rapid and easily accessible technique. Moreover, it has the additional benefit of avoiding invasive coronary angiography in the specific population of patients without any significant risk factors of atheromatous disease.
Detailed Description
Introduction: diagnosis of acute myocarditis is challenging in the specific population of patients without any significant risk factors of atheromatous disease.
Both cardiac MRI and coronary angiography (cardiac CT, invasive coronary angiography) are usually performed for the definitive diagnosis of myocarditis and for ruling out a coronary artery disease.
Spectral cardiac CT could be particularly useful in suspected myocarditis in the setting of acute chest pain in this specific population of patients with low cardiovascular risk factors. Indeed, both coronary arteries and myocardial tissue can be assessed on the same technique (cardiac CT scan) which offers the advantages of being non-invasive, more available and more easily used than MRI in emergency situations. Cardiac CT allows the detection of abnormal myocardial territories by showing subepicardial iodinated contrast enhancement with the spectral mode imaging. It also allows the direct visualization of coronary arteries, thus preventing the necessity of performing coronary angiography in a significant number of patients with suspected myocarditis in the setting of acute chest pain.
Primary objective: to evaluate the diagnostic accuracy of spectral cardiac CT imaging for the diagnosis of acute myocarditis using cardiac MRI as the gold standard, in patients with suspected myocarditis in the setting of acute chest pain. The diagnosis of acute myocarditis using spectral cardiac CT scan will be based on the presence of late subepicardial contrast enhancement detected using iodine imaging obtained after subtraction of water imaging. The gold standard will be the diagnosis of acute myocarditis based on the state-of-the-art MRI criteria.
Secondary objective: to assess the radiation dose delivered in spectral cardiac CT scan using the latest generation of machines from different manufacturers (such as GE Healthcare and Siemens).
Experimental plan: Multicenter diagnostic accuracy study, conducted within the scope of routine care of patients admitted for suspected acute myocarditis, conducted according to the Standards for the Reporting of Diagnostic (STARD) guidelines. Clinical, laboratory, cardiac MRI, and invasive coronary angiography are performed in routine care. Cardiac MRI serves as the reference standard for the definitive diagnosis of acute myocarditis. Cardiac CT is also performed in routine care in order to rule out a coronary disease. The investigators will add a second acquisition using the spectral mode imaging in order to identify inflammatory areas of the myocardium on the iodine map imaging.
All patients will undergo both cardiac CT scan with spectral mode acquisition and cardiac MRI to avoid work-up bias. Spectral CT imaging and cardiac MRI will be performed within 72 hours.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Suspected Acute Myocarditis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
136 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Spectral cardiac CT scan
Arm Type
Experimental
Arm Description
All patients will undergo cardiac CT scan with spectral mode acquisition
Intervention Type
Procedure
Intervention Name(s)
Spectral cardiac CT scan
Intervention Description
Cardiac CT scan : acquisition using the spectral mode imaging in order to identify inflammatory areas of the myocardium on the iodine map imaging.
Primary Outcome Measure Information:
Title
Diagnosis of acute myocarditis using spectral cardiac CT scan
Description
The test under study is the spectral cardiac CT scan. Diagnosis of acute myocarditis using spectral cardiac CT scan will be based on the presence of a contrast enhancement involving the subepicardial layers of the myocardial.
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Radiation dose delivered in spectral cardiac CT scan
Description
The radiation dose delivered in spectral cardiac CT scan using the latest generation of machines from different manufacturers (GE Healthcare and Siemens)
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged at least 18 years
Patient having had a preliminary clinical examination:
eligible patients must present an increased level of troponin I (>laboratory threshold) associated with at least one of the 3 following criteria: i) prolonged chest pain > 10 minutes; ii) recent viral infectious illness <7 days; iii) patients without any history of coronary disease and/or free of cardiovascular risk factors
- Patient's written informed consent.
Exclusion Criteria:
Iodine contrast allergy
Severe renal impairment (GFR < 45 ml/min)
Patient status: insufficient patient cooperation or dyspnea or hemodynamic instability with inability to hold a 8-10 seconds breath hold
Pregnant women
History of coronary artery disease
Contra indications to MRI
Patient under guardianship or trusteeship
Non affiliation to social security or CMU (beneficiary or assignee)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Phalla OU, MD PhD
Phone
00 33 1 40 25 81 01
Email
phalla.ou@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phalla OU, MD PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bichat Claude Bernard Hospital
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phalla OU, MD, PhD
Email
phalla.ou@aphp.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of Spectral Cardiac CT for the Diagnosis of Acute Myocarditis
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