- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01897350
Myocardial Oedema in ST Segment Elevation Myocardial Infarction Myocardial
October 20, 2014 updated by: Elisa McAlindon
Cardiac magnetic resonance imaging (CMR) is a non invasive technique used to obtain functional and anatomical information on the heart.
Several CMR parameters measured after primary percutaneous coronary intervention (PPCI) have been shown to have prognostic value and are increasingly being used as surrogate endpoints in clinical trials.
Myocardial oedema is a prognostic indicator following myocardial infarction1.
Myocardial salvage is calculated as the myocardial oedema minus infarct size; this again is a prognostic indicator following STEMI.
However, myocardial oedema imaging is controversial.
There are multiple sequences available, with no standardisation of sequences used to assess this surrogate endpoint.
The investigators propose to conduct a study to measure the myocardial oedema by all available techniques to determine the agreement between these methods.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Avon
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Bristol, Avon, United Kingdom, BS2 8HW
- Bristol Heart Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
30 patients will be undergo a CMR scan day 2 following STEMI
Description
Inclusion Criteria:
- STEMI
- providing written informed consent
Exclusion Criteria:
- contraindication to CMR,
- atrial fibrillation,
- claustrophobia,
- eGFR < 30
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
CMR following ST segment myocardial infarction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The mass of myocardial oedema measured by CMR
Time Frame: Day 2 following STEMI
|
Day 2 following STEMI
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Extra cellular volume
Time Frame: Day 2 following STEMI
|
Day 2 following STEMI
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
July 8, 2013
First Submitted That Met QC Criteria
July 11, 2013
First Posted (Estimate)
July 12, 2013
Study Record Updates
Last Update Posted (Estimate)
October 21, 2014
Last Update Submitted That Met QC Criteria
October 20, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Study 1953
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on ST Segment Elevation Myocardial Infarction
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Inha University HospitalCompletedST Segment Elevation Myocardial Infarction | Non-ST Segment Elevation Myocardial InfarctionKorea, Republic of
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University Hospital, Basel, SwitzerlandUniversity of BaselRecruitingNSTEMI - Non-ST Segment Elevation MI | ST-segment Elevation Myocardial Infarction (STEMI) | Acute Cardiovascular DiseaseSwitzerland
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Azienda ULSS 5 PolesanaUniversity of PadovaUnknownMyocardial Infarction, Acute | ST Segment Elevation Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Italy
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RenJi HospitalCompletedST Segment Elevation Myocardial Infarction
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Dong-A UniversityTerminatedST-Segment Elevation Myocardial InfarctionKorea, Republic of
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Azienda Ospedaliera San Camillo ForlaniniUnknownST Segment Elevation Myocardial InfarctionItaly
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Jinan Central HospitalUnknownST-Segment Elevation Myocardial InfarctionChina
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Haseki Training and Research HospitalCompletedAcute Coronary Syndrome | ST-segment Elevation Myocardial Infarction (STEMI) | Major Adverse Cardiac Events | Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)Turkey
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Assiut UniversityNot yet recruitingST-segment Elevation Myocardial Infarction (STEMI)
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Assiut UniversityUnknownST-segment Elevation Myocardial Infarction (STEMI)
Clinical Trials on Cardiac magnetic resonance imaging
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RWTH Aachen UniversityHeidelberg UniversityCompletedAcute Myocardial InfarctionGermany
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Chinese Academy of Medical Sciences, Fuwai HospitalNational Natural Science Foundation of China; Beijing Natural Science FoundationRecruitingMyocardial Infarction (MI) | Ischemic Heart Disease (IHD)China
-
Chinese Academy of Medical Sciences, Fuwai HospitalRecruiting
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Azienda Ospedaliero, Universitaria Ospedali RiunitiFondazione Toscana Gabriele Monasterio; SICP WG CMR/CTRecruitingTetralogy of Fallot | Cardiac Arrhythmia | Cardiac Event | Cardiac Death, SuddenItaly
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Centro Medico TeknonRecruitingMyocardial Infarction | Arrhythmias, Cardiac | Ventricular Tachycardia | Ventricular Arrythmia | Sudden Cardiac Death | Myocardial Infarction Old | Sudden Cardiac Death Due to Cardiac ArrhythmiaSpain
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Chinese Academy of Medical Sciences, Fuwai HospitalNational Heart, Lung, and Blood Institute (NHLBI); Peking Union Medical College... and other collaboratorsRecruitingCardiac Failure | Bundle-Branch Block, Left | ICD/Pacemaker Implantation | Cardiovascular Magnetic Resonance ImagingChina
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The Affiliated Hospital of Xuzhou Medical UniversityActive, not recruiting
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Central Hospital, Nancy, FranceCompletedPulmonary Arterial HypertensionFrance
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The Affiliated Hospital of Xuzhou Medical UniversityActive, not recruitingHeart Failure With Preserved Ejection Fraction | HFpEFChina
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University of GiessenCompletedPulmonary Arterial Hypertension | Pulmonary Hypertension | Chronic Thromboembolic Pulmonary HypertensionGermany