Adenosine's Effect on STunning Resolution in Acute Myocardial Infarction

NCT05014061 | Withdrawn Phase 3

• 1 other identifier: EudraCT number: 2021-001466-37
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Myocardial Ischemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Infarct size

  6 months

• Ejection fraction

  Day 1, Day 2, Day 3, Day 7, Day 14, Day 30 and 6 months

• Sustained ventricular tachycardia or fibrillation

  72 hours

• High-grade atrioventricular block or sinus arrest

  72 hours

• Cardiac assist device

  72 hours

Study Arms (2)

Adenosine

EXPERIMENTAL

Adenosine infusion 70 µg/kg/min initiated prior to revascularization and maintained for 6 hours

Drug: Adenosine

Controll

NO INTERVENTION

Standard of care

Interventions

Adenosine DRUG

Adenosine infusion 70 µg/kg/min for 6 hours

Adenosine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years.
• Anterior STEMI.
• Symptom duration ≤6 hours
• Culprit lesion in LAD, major branch of LAD, proximal or mid LCx or proximal or mid RCA
• TIMI flow ≤2 in the culprit vessel
• Detectable hypo- or akinesia corresponding to ≥5% of the left ventricle corresponding to culprit lesion, per bedside visual assessment.

You may not qualify if:

• 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
• 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 -

Sponsors & Collaborators

• Vastra Gotaland Region: lead

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Adenosine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Björn Redfors, MD, PhD

  Vastra Gotaland Region

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Single center, open-label, randomized controlled trial

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: August 20, 2021
• Study Start: January 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 17, 2024

Record last verified: 2021-07