Cardiac Magnetic Resonance Utilities in the Evaluation of Ischemic Heart Disease

Myocardial Ischemia Clinical Trial

— CARDIO-RM  

Official title:

CARDIAC MAGNETIC RESONANCE UTILITIES IN THE EVALUATION OF ISCHEMIC HEART DISEASE: Topographical Correlation Between Ischemic Territory Injury and Coronary Angiography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01397357
• Other study ID #: ESREFO02
• Status: Completed
• Phase: N/A
• First received: July 18, 2011
• Last updated: September 30, 2016
• Start date: July 2011
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Ettore Sansavini Health Science Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemia
• Myocardial Ischemia

Intervention

Other:
• Cardiac magnetic resonance - CINE MRI stress test.
Cardiac magnetic resonance - dipyridamole or dobutamine MRI stress test.

Locations

Country	Name	City	State
Italy	Maria Cecilia Hospital	Cotignola	RA

Sponsors (1)

Lead Sponsor	Collaborator
Ettore Sansavini Health Science Foundation

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of Cardio-RM identifying ischemic territories	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.	1 month	No
Secondary	correlation between resonance and coronary artery disease documented coronary angiography.	comparison of diagnostic positivity for inducible ischemia assessed by Cardiac-MRI and the presence of coronary lesions of various degrees evaluated by coronary angiography	1 month	No
Secondary	topographic correlation between ischemic territory and coronary lesions	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.	1 month	No