Myocardial IschemiaCARDIO-RMNCT01397357
Cardiac Magnetic Resonance Utilities in the Evaluation of Ischemic Heart Disease
An observational study of Myocardial Ischemia, run by Ettore Sansavini Health Science Foundation at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- Cardiac magnetic resonance - CINE MRI stress test.
- How many people
- 146 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2011to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Unstable angina;
- Severe aortic stenosis
- Hypertrophic cardiomyopathy
- Pacemaker and \ or defibrillator
- Coronary stent implantation in 90 days before Cardiac MRI
- Intracranial metal clips
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Myocardial Ischemia
- Being tested
- Cardiac magnetic resonance - CINE MRI stress test.
- Keywords
- Cardiac magnetic resonance, Myocardial Ischemia, Coronary Artery Disease, suspected Myocardial Ischemia
- Medical subject headings
- Myocardial Ischemia, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac magnetic resonance - CINE MRI stress test.Other
Cardiac magnetic resonance - dipyridamole or dobutamine MRI stress test.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cardiac magnetic resonance - CINE MRI stress test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (2)
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
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ettore Sansavini Health Science Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397357
- Sponsor's protocol ID
- ESREFO02
- Acronym
- CARDIO-RM
- Status last verified
- May 2015
- First submitted
- 18 Jul 2011
- Last updated
- 3 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARDIAC MAGNETIC RESONANCE UTILITIES IN THE EVALUATION OF ISCHEMIC HEART DISEASE: Topographical Correlation Between Ischemic Territory Injury and Coronary Angiography
- ClinicalTrials.gov ID
- NCT01397357
- Acronym / sponsor ID
- CARDIO-RM / ESREFO02
- Conditions
- Myocardial Ischemia
- Keywords
- Cardiac magnetic resonance, Myocardial Ischemia, Coronary Artery Disease, suspected Myocardial Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Ettore Sansavini Health Science FoundationUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 19 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| suspected Myocardial Ischemia | – | Other: 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- patients with suspected ischemic heart disease or recurrent Myocardial ischemic symptoms defined as:
- no contraindications to perform coronary angiography
- informed written consent to the processing of personal and sensible data, signed and dated by the patient.
Key exclusion criteria (13 listed)
- Unstable angina;
- Severe aortic stenosis
- Hypertrophic cardiomyopathy
- Pacemaker and \ or defibrillator
- Coronary stent implantation in 90 days before Cardiac MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac magnetic resonance - CINE MRI stress test.Cardiac magnetic resonance - dipyridamole or dobutamine MRI stress test. | Other | suspected Myocardial Ischemia |
Primary outcome
Accuracy of Cardio-RM identifying ischemic territories
Time frame: 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.
2 secondary outcomes
correlation between resonance and coronary artery disease documented coronary angiography.
Time frame: 1 month
topographic correlation between ischemic territory and coronary lesions
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2016.
- Individual participant dataSharing planned: No
Related trials for Myocardial Ischemia
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Ischemia, run by Ettore Sansavini Health Science Foundation at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Cardio-RM identifying ischemic territories (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2016.