Cardiac Magnetic Resonance Utilities in the Evaluation of Ischemic Heart Disease

NCT01397357 | Completed DMC

• 1 other identifier: ESREFO02
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Ischemia

Keywords

Cardiac magnetic resonance; Myocardial Ischemia; Coronary Artery Disease; suspected Myocardial Ischemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• correlation between resonance and coronary artery disease documented coronary angiography.

  1 month

• topographic correlation between ischemic territory and coronary lesions

  1 month

Study Arms (1)

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.

Interventions

Cardiac magnetic resonance - CINE MRI stress test. OTHER

Cardiac magnetic resonance - dipyridamole or dobutamine MRI stress test.

suspected Myocardial Ischemia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• no contraindications to perform coronary angiography
• informed written consent to the processing of personal and sensible data, signed and dated by the patient.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ettore Sansavini Health Science Foundation: lead

Study Sites (1)

Maria Cecilia Hospital

Cotignola, RA, 48010, Italy

Location

MeSH Terms

Conditions

Myocardial Ischemia; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2011
• First Posted: July 19, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: October 3, 2016

Record last verified: 2015-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)