Magnetocardiography as a Tool for Patients Presenting With Chest Pain - Pilot Study

NCT02359773 | Completed DMC

• 1 other identifier: QI CIP 001 Rev 001
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot research study is to identify the characteristics of magnetocardiograms that correlate with a non ischemic chest pain status and a myocardial infarction patient status. The study uses a non SQUID magnetocardiogram device.

Conditions

Chest Pain

Keywords

Magnetocardiography; Myocardial Infarction; Non-ischaemic chest pain

Outcome Measures

Primary Outcomes (1)

• Magnetocardiogram Characteristics in patients with chest pain

  Quantitative comparison of magnetocardiogram characteristics of non ischaemic chest pain patients compared to those with an acute myocardial infarction

  1 hour

Secondary Outcomes (1)

• Device Safety

  At time of scan for all patiients (Varies)

Study Arms (2)

Group 1 - Non ischemic chest pain

No coronary artery disease (CAD) as confirmed by myoview, MRI or stress echo. Subjects will receive one MCG scan (intervention) using the QI Model 1.0 Magentocardiogram. This will be in addition to their current care and it will not be used to support clinical decision making.

Group 2 - Myocardial infarction

Myocardial infarction confirmed by a troponin test (\>50ng/l) 12 hours after the onset of chest pain. Subjects will receive one MCG scan (intervention) using the QI Model 1.0 Magentocardiogram. This will be in addition to their current care and it will not be used to support clinical decision making.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting in Accident and Emergency Department with chest pain of presumed ischemic origin

You may qualify if:

• Subjects will be males or females over the age of 18.
• Subjects will have experienced chest pain within the last 8 weeks and have been subsequently referred to the rapid access chest pain clinic (RACPC).
• Subjects will have no coronary artery disease/ischemia as demonstrated by one of the following: MRI, myoview or stress echo within no less than 4 weeks prior to the magnetocardiogram (MCG) scan.
• Subjects will have given written informed consent to participate in the study.
• Subjects will be males or females over the age of 18.
• Subjects will have experienced chest pain and have been admitted to the cardiology unit.
• Subjects will have an abnormal level of Troponin (≥50ng/l) taken at 12 hours following the onset of chest pain.
• Subjects will be suitable to have an MCG scan taken within 48 hours of the onset of chest pain and prior to coronary angioplasty or any other surgical intervention.
• Subjects will have given written informed consent to participate in the study.

You may not qualify if:

• Subjects with symptoms suggestive of acute coronary syndrome that require further investigation.
• Subjects who had an abnormal level of Troponin (≥50ng/l) - as determined by a test performed prior to referral to the RACPC.
• Subjects who have a pacemaker or internal cardiac defibrillator.
• Subjects with an active implantable device.
• Subjects with ferrous implants in the torso including wires or ferrous stents.
• Subjects who are pregnant.
• Subjects who are unable to lie in a supine position.
• Subjects with any comorbidity that prevents them being scanned.
• Subjects who have had a STEMI.
• Patients with haemodynamic instability (dysrhythmia or hypotension).
• Subjects who have had a revascularisation technique performed prior to an MCG scan.
• Subjects who have a pacemaker or internal cardiac defibrillator.
• Subjects with ferrous implants in the torso including wires or ferrous stents.
• Subjects with an active implantable device.
• Subjects who are pregnant.

Sponsors & Collaborators

• Quantum Imaging Limited: lead

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS2 9DF, United Kingdom

Location

MeSH Terms

Conditions

Chest Pain; Myocardial Infarction

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Mark Kearney, MBChB FRCP

  Leeds Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: February 10, 2015
• Study Start: February 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 4, 2015

Record last verified: 2015-02

Locations

GB (1)