STEMIMicro-AMINCT01552564
The Microcirculation in Acute Myocardial Infarction (Micro-AMI)
An observational study of STEMI, run by University of Bristol at 1 site in United Kingdom.
Trial summary
This study investigates the association between the microvascular resistance at the time of primary percutaneous intervention, with microvascular obstruction on CMR and blood markers of myocardial damage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI
- What is being tested?
- Index of microvascular resistance, Cardiac magnetic resonance and Blood markers
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2012to Jan 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: STEMI attending Bristol Heart Institute via the primary PCI service
Who may be able to join
- >18 years old
- Cardiac symptoms of > 20 mins chest pain or equivalent.
- ECG criteria consistent with STEMI (STEMI)
- Proceeding with percutaneous angioplasty
- Assent/ consent to the study
Who cannot join
- Known allergy to adenosine or gadolinium
- Chronic atrial fibrillation
- Renal impairment with eGFR <30
- Contraindication to angiography
- Contraindication to CMR (implanted pacemaker/ defibrillator, ferromagnetic metal implant/ injury, claustrophobia, obesity/ too large for CMR scanner)
- Cardiogenic shock
- Patients with special communication needs or altered consciousness.
- Patients who do not give assent/consent to the study
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates the association between the microvascular resistance at the time of primary percutaneous intervention, with microvascular obstruction on CMR and blood markers of myocardial damage.
- Conditions
- STEMI
- Being tested
- Index of microvascular resistance, Cardiac magnetic resonance, Blood markers
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Index of microvascular resistanceProcedure or surgery
Cardiac magnetic resonanceOther
Blood markersOther
| Study group | Role | What they receive |
|---|---|---|
| STEMI patients | Consecutive patients presenting through the PPCI service Receives: Procedure: Index of microvascular resistance; Other: Cardiac magnetic resonance; Other: Blood markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular obstruction
Microvascular obstruction as a percentage of the left ventricle at 2-4 days.
Measured: DAy 2-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for STEMIStudies 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bristol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisa McAlindon, University of Bristol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552564
- Sponsor's protocol ID
- 1625
- Acronym
- Micro-AMI
- Status last verified
- Oct 2014
- First submitted
- 9 Mar 2012
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McAlindon E, Pufulete M, Harris J, Lawton C, Johnson T, Strange J, Baumbach A, Bucciarelli-Ducci C. Microvascular dysfunction determines infarct characteristics in patients with reperfused ST-segment elevation myocardial infarction: The MICROcirculation in Acute Myocardial Infarction (MICRO-AMI) study. PLoS One. 2018 Nov 13;13(11):e0203750. doi: 10.1371/journal.pone.0203750. eCollection 2018.
PubMed 30422990
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Microcirculation in Acute Myocardial Infarction (Micro-AMI)
- ClinicalTrials.gov ID
- NCT01552564
- Acronym / sponsor ID
- Micro-AMI / 1625
- Conditions
- STEMI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of BristolUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jan 2014 (actual)
- First posted
- 13 Mar 2012 (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.
This study investigates the association between the microvascular resistance at the time of primary percutaneous intervention, with microvascular obstruction on CMR and blood markers of myocardial damage.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STEMI patients | – | Procedure: Index of microvascular resistance, Other: Cardiac magnetic resonance, Other: Blood markersConsecutive patients presenting through the PPCI service |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- STEMI attending Bristol Heart Institute via the primary PCI service
Key inclusion criteria (5 listed)
- >18 years old
- Cardiac symptoms of > 20 mins chest pain or equivalent.
- ECG criteria consistent with STEMI (STEMI)
- Proceeding with percutaneous angioplasty
- Assent/ consent to the study
Key exclusion criteria (8 listed)
- Known allergy to adenosine or gadolinium
- Chronic atrial fibrillation
- Renal impairment with eGFR <30
- Contraindication to angiography
- Contraindication to CMR (implanted pacemaker/ defibrillator, ferromagnetic metal implant/ injury, claustrophobia, obesity/ too large for CMR scanner)
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 |
|---|---|---|
| Index of microvascular resistance | Procedure or surgery | STEMI patients |
| Cardiac magnetic resonance | Other | STEMI patients |
| Blood markers | Other | STEMI patients |
Primary outcome
Microvascular obstruction
Time frame: DAy 2-4
Microvascular obstruction as a percentage of the left ventricle at 2-4 days.
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 28 Oct 2014.
- Derived from this study: PubMed 30422990McAlindon E, Pufulete M, Harris J, Lawton C, Johnson T, Strange J, Baumbach A, Bucciarelli-Ducci C. Microvascular dysfunction determines infarct characteristics in patients with reperfused ST-segment elevation myocardial infarction: The MICROcirculation in Acute Myocardial Infarction (MICRO-AMI) study. PLoS One. 2018 Nov 13;13(11):e0203750. doi: 10.1371/journal.pone.0203750. eCollection 2018.
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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.
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 STEMI, run by University of Bristol at 1 site in United Kingdom.
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 5 inclusion and 8 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 28 Oct 2014. 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 United Kingdom. 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?
Microvascular obstruction (time frame: DAy 2-4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01552564, which also lists 1 linked publication.
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 28 Oct 2014.