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

This study is currently recruiting participants.
Verified March 2012 by Ettore Sansavini Health Science Foundation
Sponsor:
Information provided by (Responsible Party):
Ettore Sansavini Health Science Foundation
ClinicalTrials.gov Identifier:
NCT01397357
First received: July 18, 2011
Last updated: February 25, 2013
Last verified: March 2012
  Purpose

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.


Condition Intervention
Myocardial Ischemia
Other: Cardiac magnetic resonance - CINE MRI stress test.

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: CARDIAC MAGNETIC RESONANCE UTILITIES IN THE EVALUATION OF ISCHEMIC HEART DISEASE: Topographical Correlation Between Ischemic Territory Injury and Coronary Angiography

Resource links provided by NLM:


Further study details as provided by Ettore Sansavini Health Science Foundation:

Primary Outcome Measures:
  • Accuracy of Cardio-RM identifying ischemic territories [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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:
  • correlation between resonance and coronary artery disease documented coronary angiography. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    comparison of diagnostic positivity for inducible ischemia assessed by Cardiac-MRI and the presence of coronary lesions of various degrees evaluated by coronary angiography

  • topographic correlation between ischemic territory and coronary lesions [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 350
Study Start Date: July 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01397357

Contacts
Contact: Giulia Schiavina +390545217032 gschiavina@esrefo.org
Contact: Luca Dozza +390545217175 ldozza@esrefo.org

Locations
Italy
Maria Cecilia Hospital Recruiting
Cotignola, RA, Italy, 48010
Principal Investigator: Stefano Bosi, MD         
Sub-Investigator: Monica Naldi, MD         
Sub-Investigator: Alessandra Barbieri, MD         
Sub-Investigator: Claudio Marri, MD         
Sponsors and Collaborators
Ettore Sansavini Health Science Foundation
  More Information

No publications provided

Responsible Party: Ettore Sansavini Health Science Foundation
ClinicalTrials.gov Identifier: NCT01397357     History of Changes
Other Study ID Numbers: ESREFO02
Study First Received: July 18, 2011
Last Updated: February 25, 2013
Health Authority: Italy: National Medicines Agency

Keywords provided by Ettore Sansavini Health Science Foundation:
Cardiac magnetic resonance
Myocardial Ischemia
Coronary Artery Disease
suspected Myocardial Ischemia

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Heart Diseases
Ischemia
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014