Myocardial InfarctionSAVEMENCT02517255
Salvage of Myocardial Infarction Documented by MRI in Patients Undergoing Rescue Percutaneous Coronary Intervention
A study testing Cardiac Magnetic Resonance Imaging in people with Myocardial Infarction and Myocardial Ischemia, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Atherosclerotic disease is responsible for one third of all deaths annually and is a major cause of comorbidities. While atherosclerosis is by itself a benign disease, it often leads to complications such as acute myocardial infarction with ST-segment elevation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Myocardial Ischemia
- What is being tested?
- Cardiac Magnetic Resonance Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2015to Apr 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ST segment elevation myocardial infarction (STEMI) who underwent Thrombolysis within 12 hours of chest pain and present clinical and/or electrocardiogram (EKG) signs of failed thrombolysis with indication of rescue percutaneous coronary intervention (PCI).
Who cannot join
- Patients with contraindication to Cardiac Magnetic Resonance Imaging (MRI) (pacemaker, aneurysm clip, claustrophobia, hemodynamic instability, etc).
- Allergy or contraindication to Gadolinium.
- Contraindication to dual anti-platelet therapy.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Escola Paulista de Medicina - Universidade Federal de São Paulo
São Paulo, São Paulo, 04023-062
About this study
Official title: Salvage of Myocardial Infarction Documented by Magnetic Resonance Imaging in Patients Undergoing Rescue Percutaneous Coronary Intervention
Atherosclerotic disease is responsible for one third of all deaths annually and is a major cause of comorbidities. While atherosclerosis is by itself a benign disease, it often leads to complications such as acute myocardial infarction with ST-segment elevation. Rescue angioplasty is indicated if thrombolytic therapy fails. However, the benefits in reducing mortality and the amount of myocardium effectively saved are not well established. The development of new tools, including cardiac magnetic resonance imaging to identify myocardial area at risk and infarcted increased diagnostic accuracy. However, unlike the context of primary angioplasty, little is known about the relation between coronary epicardial and microvascular flow after rescue angioplasty and myocardial salvage. The objective of this study is to evaluate whether there is a relation between these flows and myocardial salvage identified by Magnetic Resonance Imaging (MRI). At the end of this research, the investigators hope to contribute to a better understanding of coronary flow and its relation to the amount of heart muscle saved after rescue angioplasty. This is an important information that can help understand which cases benefit most from rescue angioplasty.
- Conditions
- Myocardial Infarction, Myocardial Ischemia
- Being tested
- Cardiac Magnetic Resonance Imaging
- Keywords
- ST segment elevation myocardial infarction, Failed Thrombolysis, Rescue Percutaneous Coronary Intervention, Cardiac Magnetic Resonance Imaging
- Medical subject headings
- Myocardial Infarction, Myocardial Ischemia, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Magnetic Resonance ImagingDevice
7 day-Cardiac MRI: T1 and T2 images; 3 and 6 month-Cardiac MRI: T1, T2 and stress perfusion images
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Magnetic Resonance Imaging | Experimental | Cardiac MRI will be performed within 7 days of rescue percutaneous coronary intervention (PCI) and after 3 and 6 months. Receives: Device: Cardiac Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular obstruction - percentage of left ventricular mass displaying a lack of contrast uptake in the core of an area showing delayed enhancement.
Measured: 6 months
Secondary outcomes (1)
Infarct size - percentage of left ventricular mass with signal intensity 2 standard deviations above the mean signal obtained in the remote non-infarcted myocardium.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2017
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Luiz Fernando Ybarra, Federal University of São Paulo
- Investigators
- Antonio C Carvalho, MD, PhD, Study chair, Full Professor at Universidade Federal de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517255
- Sponsor's protocol ID
- 518.844
- Acronym
- SAVEME
- Status last verified
- Feb 2019
- First submitted
- 27 Jul 2015
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salvage of Myocardial Infarction Documented by Magnetic Resonance Imaging in Patients Undergoing Rescue Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT02517255
- Acronym / sponsor ID
- SAVEME / 518.844
- Conditions
- Myocardial Infarction, Myocardial Ischemia
- Keywords
- ST segment elevation myocardial infarction, Failed Thrombolysis, Rescue Percutaneous Coronary Intervention, Cardiac Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jul 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Apr 2019 (estimated)
- First posted
- 6 Aug 2015 (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.
Atherosclerotic disease is responsible for one third of all deaths annually and is a major cause of comorbidities. While atherosclerosis is by itself a benign disease, it often leads to complications such as acute myocardial infarction with ST-segment elevation. Rescue angioplasty is indicated if thrombolytic therapy fails. However, the benefits in reducing mortality and the amount of myocardium effectively saved are not well established. The development of new tools, including cardiac magnetic resonance imaging to identify myocardial area at risk and infarcted increased diagnostic accuracy. However, unlike the context of primary angioplasty, little is known about the relation between coronary epicardial and microvascular flow after rescue angioplasty and myocardial salvage. The objective of this study is to evaluate whether there is a relation between these flows and myocardial salvage identified by Magnetic Resonance Imaging (MRI). At the end of this research, the investigators hope to contribute to a better understanding of coronary flow and its relation to the amount of heart muscle saved after rescue angioplasty. This is an important information that can help understand which cases benefit most from rescue angioplasty.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Magnetic Resonance Imaging | Experimental | Device: Cardiac Magnetic Resonance ImagingCardiac MRI will be performed within 7 days of rescue percutaneous coronary intervention (PCI) and after 3 and 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with ST segment elevation myocardial infarction (STEMI) who underwent Thrombolysis within 12 hours of chest pain and present clinical and/or electrocardiogram (EKG) signs of failed thrombolysis with indication of rescue percutaneous coronary intervention (PCI).
Key exclusion criteria (3 listed)
- Patients with contraindication to Cardiac Magnetic Resonance Imaging (MRI) (pacemaker, aneurysm clip, claustrophobia, hemodynamic instability, etc).
- Allergy or contraindication to Gadolinium.
- Contraindication to dual anti-platelet therapy.
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 Imaging7 day-Cardiac MRI: T1 and T2 images; 3 and 6 month-Cardiac MRI: T1, T2 and stress perfusion images | Device | Cardiac Magnetic Resonance Imaging |
Primary outcome
Microvascular obstruction - percentage of left ventricular mass displaying a lack of contrast uptake in the core of an area showing delayed enhancement.
Time frame: 6 months
1 secondary outcome
Infarct size - percentage of left ventricular mass with signal intensity 2 standard deviations above the mean signal obtained in the remote non-infarcted myocardium.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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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.
Antonio C Carvalho, MD, PhD study chair
Full Professor at Universidade Federal de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Magnetic Resonance Imaging in people with Myocardial Infarction and Myocardial Ischemia, run by Federal University of São Paulo at 1 site in Brazil.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Feb 2019. 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 Brazil. 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?
Results are not available in the source record.
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?
Microvascular obstruction - percentage of left ventricular mass displaying a lack of contrast uptake in the core of an area showing delayed enhancement. (time frame: 6 months). 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 15 Feb 2019.