Myocardial IschemiaPhase 3A-STAMINCT05014061
Adenosine's Effect on STunning Resolution in Acute Myocardial Infarction
A Phase 3 study testing Adenosine in people with Myocardial Ischemia, run by Vastra Gotaland Region.
Trial summary
The aim of this study is to evaluate the effect of adenosine on the recovery of myocardial akinesia in ST-elevation myocardial infarction (STEMI). The study is a single-center randomized clinical trial intending to include 90 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- Adenosine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to Dec 2025
- Phase
- Phase 3
- 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
- Age >18 years.
- Anterior STEMI.
- Symptom duration ≤6 hours
- Written informed consent obtained - Angiographic Inclusion criteria:
- Culprit lesion in LAD, major branch of LAD, proximal or mid LCx or proximal or mid RCA
- TIMI flow ≤2 in the culprit vessel
- -Echocardiographic inclusion criteria:
- Detectable hypo- or akinesia corresponding to ≥5% of the left ventricle corresponding to culprit lesion, per bedside visual assessment.
Who cannot join
- Previous randomization in the study
- Any of the following contraindications for treatment with adenosine:
- Known pre-existing atrioventricular block grade ≥2 or sick sinus syndrome in patients without pacemaker.
- Known pre-existing elevation of intracranial pressure
- Treatment with dipyridamole within 24 hours of randomization
- Systolic blood pressure <80 mm Hg at screening
Show all 11Show fewer
- Any concomitant condition resulting in a life expectancy of less than one month
- Previous myocardial infarction or other cardiac condition resulting in impaired regional or global systolic function without documented recovery of cardiac function
- Heart transplant or left ventricular assist device recipient
- Not suitable in the opinion of the investigator due to severe or terminal comorbidity with poor prognosis or characteristics that may interfere with adherence to the trial protocol
- Pregnancy or woman of childbearing potential who is not sterilized or using a medically accepted form of contraception -
About this study
Official title: Adenosine's Effect on STunning Resolution in Acute Myocardial Infarction An Open-label, Single Center Trial
The aim of this study is to evaluate the effect of adenosine on the recovery of myocardial akinesia in ST-elevation myocardial infarction (STEMI). The study is a single-center randomized clinical trial intending to include 90 patients.
The objective of the study is to investigate whether treatment with adenosine hastens recovery of myocardial akinesia and improves cardiac function at 48 hours in patients with STEMI.
Read the detailed description
Primary endpoint (variable):
The resolution of myocardial stunning at 48 hours (StunningRes48h).
The proportion of stunning that has resolved at 48 hours will be calculated according to the formula:
StunningRes48h = (%AkinesiaBaseline - %Akinesia48h) / (%AkinesiaBaseline - %Akinesia30days) where %AkinesiaT is defined as the endocardial length of the akinetic myocardium measured in end-diastole divided by the total endocardial length measured in end-diastole in the 2- and 4-chamber view, at time T (T= 48h or 30 days)
Secondary endpoint(s) (variables):
- Infarct size at 6 months, as assessed by cardiac magnetic resonance imaging (magnetic resonance imaging).
- Ejection fraction days 1, 2, 3, 7, 14, 30 and 6 months.
- Any sustained ventricular tachycardia or fibrillation within 72 hours (safety endpoint; binary)
- Any high-grade atrioventricular block or sinus arrest within 72 hours (safety endpoint; binary)
- Implantation of cardiac assist device within 72 hours (binary)
- Stroke within 6 months (binary)
- All-cause mortality within 6 months
- Heart failure rehospitalization within 6 months*
- Worsening in-hospital heart failure ≥12 hours after PCI#
- Composite of any worsening in-hospital heart failure ≥12 hours after PCI or heart failure rehospitalization within 6 months.
- Defined as re-admission to hospital after discharge, with a total length of admission ≥24 hours, documented worsening of heart failure signs or symptoms (e.g. worsening dyspnea, fatigue, edema/fluid overload, pulmonary venous distension or signs of pulmonary edema on X-ray), with administration of intravenous diuretic or inotropic drugs, ultrafiltration, non-invasive ventilation or mechanical assist device.
- Defined as intensification of heart failure therapy due to worsening heart failure signs or symptoms (as above; including intravenous diuretic, inotropic or vasopressor drugs, non-invasive ventilation or mechanical assist device).
- Conditions
- Myocardial Ischemia
- Being tested
- Adenosine
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdenosineDrug
Adenosine infusion 70 µg/kg/min for 6 hours
| Study group | Role | What they receive |
|---|---|---|
| Adenosine | Experimental | Adenosine infusion 70 µg/kg/min initiated prior to revascularization and maintained for 6 hours Receives: Drug: Adenosine |
| Controll | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The resolution of myocardial stunning at 48 hours (StunningRes48h).
The proportion of stunning that has resolved at 48 hours will be calculated according to the formula:
StunningRes48h = (%AkinesiaBaseline - %Akinesia48h) / (%AkinesiaBaseline - %Akinesia30days) where %AkinesiaT is defined as the endocardial length of the akinetic myocardium measured in end-diastole divided by the total endocardial length measured in end-diastole in the 2- and 4-chamber view, at time T (T= 48h or 30 days)
Measured: 48 hours
Secondary outcomes (10)
Infarct size
Infarct size, assessed by cardiac magnetic resonance imaging
Measured: 6 months
Ejection fraction
Ejection fraction, assessed by echocardiography
Measured: Day 1, Day 2, Day 3, Day 7, Day 14, Day 30 and 6 months
Sustained ventricular tachycardia or fibrillation
Any sustained ventricular tachycardia or fibrillation within 72 hours
Measured: 72 hours
High-grade atrioventricular block or sinus arrest
Any high-grade atrioventricular block or sinus arrest within 72 hours
Measured: 72 hours
Cardiac assist device
Implantation of cardiac assist device within 72 hours
Measured: 72 hours
Stroke
Stroke within 6 months
Measured: 6 months
Mortality
All-cause mortality within 6 months
Measured: 6 months
Rehospitalization
Heart failure rehospitalization within 6 months
Measured: 6 months
Worsening heart failure
Worsening in-hospital heart failure after PCI
Measured: ≥12 hours
Composite
Composite of any worsening in-hospital heart failure ≥12 hours after PCI or heart failure rehospitalization within 6 months
Measured: ≥12 hours or 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start1 Jan 2023 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Never started
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.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single center, open-label, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Björn Redfors, MD, PhD, Principal investigator, Vastra Gotaland Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014061
- Sponsor's protocol ID
- EudraCT number: 2021-001466-37
- Acronym
- A-STAMI
- Status last verified
- Jul 2021
- First submitted
- 8 Jul 2021
- Last updated
- 17 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adenosine's Effect on STunning Resolution in Acute Myocardial Infarction An Open-label, Single Center Trial
- ClinicalTrials.gov ID
- NCT05014061
- Acronym / sponsor ID
- A-STAMI / EudraCT number: 2021-001466-37
- Conditions
- Myocardial Ischemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 20 Aug 2021 (actual)
- 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 aim of this study is to evaluate the effect of adenosine on the recovery of myocardial akinesia in ST-elevation myocardial infarction (STEMI). The study is a single-center randomized clinical trial intending to include 90 patients.
The objective of the study is to investigate whether treatment with adenosine hastens recovery of myocardial akinesia and improves cardiac function at 48 hours in patients with STEMI.
Detailed description
Primary endpoint (variable):
The resolution of myocardial stunning at 48 hours (StunningRes48h).
The proportion of stunning that has resolved at 48 hours will be calculated according to the formula:
StunningRes48h = (%AkinesiaBaseline - %Akinesia48h) / (%AkinesiaBaseline - %Akinesia30days) where %AkinesiaT is defined as the endocardial length of the akinetic myocardium measured in end-diastole divided by the total endocardial length measured in end-diastole in the 2- and 4-chamber view, at time T (T= 48h or 30 days)
Secondary endpoint(s) (variables):
- Infarct size at 6 months, as assessed by cardiac magnetic resonance imaging (magnetic resonance imaging).
- Ejection fraction days 1, 2, 3, 7, 14, 30 and 6 months.
- Any sustained ventricular tachycardia or fibrillation within 72 hours (safety endpoint; binary)
- Any high-grade atrioventricular block or sinus arrest within 72 hours (safety endpoint; binary)
- Implantation of cardiac assist device within 72 hours (binary)
- Stroke within 6 months (binary)
- All-cause mortality within 6 months
- Heart failure rehospitalization within 6 months*
- Worsening in-hospital heart failure ≥12 hours after PCI#
- Composite of any worsening in-hospital heart failure ≥12 hours after PCI or heart failure rehospitalization within 6 months.
- Defined as re-admission to hospital after discharge, with a total length of admission ≥24 hours, documented worsening of heart failure signs or symptoms (e.g. worsening dyspnea, fatigue, edema/fluid overload, pulmonary venous distension or signs of pulmonary edema on X-ray), with administration of intravenous diuretic or inotropic drugs, ultrafiltration, non-invasive ventilation or mechanical assist device.
- Defined as intensification of heart failure therapy due to worsening heart failure signs or symptoms (as above; including intravenous diuretic, inotropic or vasopressor drugs, non-invasive ventilation or mechanical assist device).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single center, open-label, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Adenosine | Experimental | Drug: AdenosineAdenosine infusion 70 µg/kg/min initiated prior to revascularization and maintained for 6 hours |
| Controll | No intervention | –Standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age >18 years.
- Anterior STEMI.
- Symptom duration ≤6 hours
- Written informed consent obtained - Angiographic Inclusion criteria:
Key exclusion criteria (11 listed)
- Previous randomization in the study
- Any of the following contraindications for treatment with adenosine:
- Any concomitant condition resulting in a life expectancy of less than one month
- Previous myocardial infarction or other cardiac condition resulting in impaired regional or global systolic function without documented recovery of cardiac function
- Heart transplant or left ventricular assist device recipient
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 |
|---|---|---|
| AdenosineAdenosine infusion 70 µg/kg/min for 6 hours | Drug | Adenosine |
Primary outcome
The resolution of myocardial stunning at 48 hours (StunningRes48h).
Time frame: 48 hours
The proportion of stunning that has resolved at 48 hours will be calculated according to the formula: StunningRes48h = (%AkinesiaBaseline - %Akinesia48h) / (%AkinesiaBaseline - %Akinesia30days) where %AkinesiaT is defined as the endocardial length of the akinetic myocardium measured in end-diastole divided by the total endocardial length measured in end-diastole in the 2- and 4-chamber view, at time T (T= 48h or 30 days)
10 secondary outcomes
Infarct size
Time frame: 6 months
Ejection fraction
Time frame: Day 1, Day 2, Day 3, Day 7, Day 14, Day 30 and 6 months
Sustained ventricular tachycardia or fibrillation
Time frame: 72 hours
High-grade atrioventricular block or sinus arrest
Time frame: 72 hours
Cardiac assist device
Time frame: 72 hours
Stroke
Time frame: 6 months
Mortality
Time frame: 6 months
Rehospitalization
Time frame: 6 months
Worsening heart failure
Time frame: ≥12 hours
Composite
Time frame: ≥12 hours or 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
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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.
Björn Redfors, MD, PhD principal investigator
Vastra Gotaland Region
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adenosine in people with Myocardial Ischemia, run by Vastra Gotaland Region.
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 8 inclusion and 11 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: withdrawn, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
The resolution of myocardial stunning at 48 hours (StunningRes48h). (time frame: 48 hours). 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 17 May 2024.