Cardiac Magnetic Resonance Utilities in the Evaluation of Ischemic Heart Disease (CARDIO-RM)

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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia
• Intervention / Treatment: Other: Cardiac magnetic resonance - CINE MRI stress test.

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 Type: Observational
• Enrollment (Actual): 146

Contacts and Locations

Study Locations

• Italy
  • RA
    • Cotignola, RA, Italy, 48010
      • Maria Cecilia Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who refer to the clinic within 12 months, 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
suspected Myocardial Ischemia; 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.	Other: Cardiac magnetic resonance - CINE MRI stress test.; Cardiac magnetic resonance - dipyridamole or dobutamine MRI stress test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Ettore Sansavini Health Science Foundation

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): March 1, 2015

Study Registration Dates

• First Submitted: July 18, 2011
• First Submitted That Met QC Criteria: July 18, 2011
• First Posted (ESTIMATE): July 19, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): October 3, 2016
• Last Update Submitted That Met QC Criteria: September 30, 2016
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Myocardial Ischemia; Cardiac magnetic resonance; suspected Myocardial Ischemia
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: ESREFO02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO