Cardiac Magnetic Resonance Utilities in the Evaluation of Ischemic Heart Disease

Completed

• Conditions: Myocardial Ischemia
• Interventions: Other: Cardiac magnetic resonance - CINE MRI stress test.

• Registration Number: NCT01397357
• Lead Sponsor: Ettore Sansavini Health Science Foundation

Brief Summary

The purpose of this study is to evaluate CARDIAC MAGNETIC RESONANCE UTILITIES IN THE ISCHEMIC HEART DISEASE as topographical correlation between ischemic territory injury and coronary angiography.

Detailed Description

Assessing the accuracy of Cardio-RM identifying ischemic territories and their correspondence to the presence of critical coronary lesions, comparing the presence, extent and regional inducible ischaemia in the Cardiac-MRI with the presence and characteristics of vascular lesions in coronary angiography.

In particular, the study aims to evaluate the correlation between topography and function of the ischemic area revealed by the resonance and coronary artery disease documented coronary angiography.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-18
• Study First Submitted QC: 2011-07-18
• Study First Posted: 2011-07-19
• Primary Completion: 2014-12
• Study Completion: 2015-03
• Status Verified: 2015-05
• Last Update Submitted: 2016-09-30
• Last Update Posted: 2016-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

1. patients with suspected ischemic heart disease or recurrent Myocardial ischemic symptoms defined as:

   • presence of:

     • chest pain related to the effort lasting 5-20 minutes, and / or
     • positive stress test for inducible Myocardial ischemia

   • presence of at least one of the following risk factors: smoke family history of cardiovascular disease hypertension dyslipidemia diabetes mellitus NID / ID

2. no contraindications to perform coronary angiography

3. informed written consent to the processing of personal and sensible data, signed and dated by the patient.

Exclusion Criteria

• Unstable angina;
• Severe aortic stenosis
• Hypertrophic cardiomyopathy
• Pacemaker and \ or defibrillator
• Coronary stent implantation in 90 days before Cardiac MRI
• Intracranial metal clips
• Severe hypertension (systolic blood pressure> 240 mmHg, and diastolic blood pressure above 120 mmHg)
• Ventricular thrombosis and \ or atrial
• Aortic aneurysm and \ or aortic dissection
• Myocarditis, endocarditis, pericarditis
• Critical stenosis of the left notes
• State of severe anxiety or claustrophobia
• Contraindications to the use of atropine (BAV advanced glaucoma, pyloric stenosis, prostatic hypertrophy)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
suspected Myocardial Ischemia	Cardiac magnetic resonance - CINE MRI stress test.	Patient with diagnosis of suspected coronary artery disease (CAD) or recurrent ischemic symptoms assessed by under-effort angina symptoms and/or cardiac conventional stress test, and the presence of at least two risk factors.

Primary Outcome Measures

Name	Time	Method
Accuracy of Cardio-RM identifying ischemic territories	1 month	Assessing the accuracy of Cardio-RM identifying ischemic territories and their correspondence to the presence of critical coronary lesions, comparing the presence, extent and regional inducible ischaemia in the Cardiac-MRI with the presence and characteristics of vascular lesions in coronary angiography.

Secondary Outcome Measures

Name	Time	Method
topographic correlation between ischemic territory and coronary lesions	1 month	topographic correlation between ischemic territory assessed by Cardiac-MRI and coronary lesions evaluated by coronary angiography, using the criteria defined in Sintax study and BARI study.
correlation between resonance and coronary artery disease documented coronary angiography.	1 month	comparison of diagnostic positivity for inducible ischemia assessed by Cardiac-MRI and the presence of coronary lesions of various degrees evaluated by coronary angiography

Trial Locations

Locations (1)

Maria Cecilia Hospital; 🇮🇹 Cotignola, RA, Italy