Adenosine's Effect on STunning Resolution in Acute Myocardial Infarction

Myocardial Ischemia Clinical Trial

— A-STAMI  

Official title:

Adenosine's Effect on STunning Resolution in Acute Myocardial Infarction An Open-label, Single Center Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05014061
• Other study ID #: EudraCT number: 2021-001466-37
• Status: Withdrawn
• Phase: Phase 3
• Start date: January 1, 2023
• Est. completion date: December 2025

Study information

• Verified date: July 2021
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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):

1. Infarct size at 6 months, as assessed by cardiac magnetic resonance imaging (magnetic resonance imaging).

2. Ejection fraction days 1, 2, 3, 7, 14, 30 and 6 months.

3. Any sustained ventricular tachycardia or fibrillation within 72 hours (safety endpoint; binary)

4. Any high-grade atrioventricular block or sinus arrest within 72 hours (safety endpoint; binary)

5. Implantation of cardiac assist device within 72 hours (binary)

6. Stroke within 6 months (binary)

7. All-cause mortality within 6 months

8. Heart failure rehospitalization within 6 months*

9. Worsening in-hospital heart failure ≥12 hours after PCI#

10. 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age >18 years.

2. Anterior STEMI.

3. Symptom duration =6 hours

4. Written informed consent obtained - Angiographic Inclusion criteria:

1. Culprit lesion in LAD, major branch of LAD, proximal or mid LCx or proximal or mid RCA

2. TIMI flow =2 in the culprit vessel

-Echocardiographic inclusion criteria:

3. Detectable hypo- or akinesia corresponding to =5% of the left ventricle corresponding to culprit lesion, per bedside visual assessment.

Exclusion Criteria:

1. Previous randomization in the study

2. Any of the following contraindications for treatment with adenosine:

1. Known pre-existing atrioventricular block grade =2 or sick sinus syndrome in patients without pacemaker.

2. Known pre-existing elevation of intracranial pressure

3. Treatment with dipyridamole within 24 hours of randomization

4. Systolic blood pressure <80 mm Hg at screening

3. Any concomitant condition resulting in a life expectancy of less than one month

4. Previous myocardial infarction or other cardiac condition resulting in impaired regional or global systolic function without documented recovery of cardiac function

5. Heart transplant or left ventricular assist device recipient

6. 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

7. Pregnancy or woman of childbearing potential who is not sterilized or using a medically accepted form of contraception -

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Drug:
• Adenosine
Adenosine infusion 70 µg/kg/min for 6 hours

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	48 hours
Secondary	Infarct size	Infarct size, assessed by cardiac magnetic resonance imaging	6 months
Secondary	Ejection fraction	Ejection fraction, assessed by echocardiography	Day 1, Day 2, Day 3, Day 7, Day 14, Day 30 and 6 months
Secondary	Sustained ventricular tachycardia or fibrillation	Any sustained ventricular tachycardia or fibrillation within 72 hours	72 hours
Secondary	High-grade atrioventricular block or sinus arrest	Any high-grade atrioventricular block or sinus arrest within 72 hours	72 hours
Secondary	Cardiac assist device	Implantation of cardiac assist device within 72 hours	72 hours
Secondary	Stroke	Stroke within 6 months	6 months
Secondary	Mortality	All-cause mortality within 6 months	6 months
Secondary	Rehospitalization	Heart failure rehospitalization within 6 months	6 months
Secondary	Worsening heart failure	Worsening in-hospital heart failure after PCI	=12 hours
Secondary	Composite	Composite of any worsening in-hospital heart failure =12 hours after PCI or heart failure rehospitalization within 6 months	=12 hours or 6 months