CMR Repeatability in STEMI

STEMI Clinical Trial

Official title:

Cardiovascular Magnetic Resonance Scan Repeatability in ST Segment Elevation Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01468662
• Other study ID #: Study 1569
• Status: Completed
• Phase: N/A
• First received: November 7, 2011
• Last updated: October 27, 2014
• Start date: November 2011

Study information

• Verified date: October 2014
• Source: University of Bristol
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

The investigators propose to conduct a study to measure the reproducibility of CMR parameters that have been used to predict outcome following PPCI: infarct size, left ventricular volumes, myocardial salvage, microvascular obstruction (MVO) and myocardial oedema.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

Participant may enter study if ALL of the following apply

1. ST segment myocardial infarction as defined by ECG (by 2 contiguous limb leads with >1 mm ST-segment elevation, or >2 mm ST-segment elevation in contiguous precordial leads, or new LBBB) and > 20 minutes of cardiac chest pain

2. Written informed consent

Exclusion Criteria:

Participant may not enter study if ANY of the following apply

1. Contraindication to MRI (implanted pacemaker/ defibrillator, ferromagnetic metal implant/ injury, claustrophobia, obesity/ too large for CMR scanner)

2. Known allergy to gadolinium

3. Chronic atrial fibrillation

4. Renal impairment with eGFR <30

5. Cardiogenic shock

6. Patients with special communication needs

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• STEMI

Locations

Country	Name	City	State
United Kingdom	Bristol Heart Institute	Bristol

Sponsors (1)

Lead Sponsor	Collaborator
University of Bristol

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inter-observer, intra-observer and inter-scan variability and agreement		Between 2 scans	No