Hyperemic mYocardial Perfusion by adEnosine at diffeRent Doses

NCT06578234 | Recruiting Phase 4

• 1 other identifier: 2023-505248-20-00
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Adenosine is a commonly used pharmaceutical stressor at cardiac magnetic resonance examinations to assess suspected chronic coronary syndrome (CCS). However, several studies have reported that the current use of adenosine does not induce adequate hyperemic response in a substantial number of patients, leading to false diagnostics. The aim of this trial is to investigate the hyperemic effect of the standard dose of adenosine (140 microgram/kg/min) to the high dose of adenosine (210 microgram/kg/min) to improve the diagnostic methods using adenosine as a stressor and ultimately improve treatment decisions and patient prognosis in CCS.

Conditions

Chronic Coronary Syndrome; Coronary Artery Disease; Ischemic Heart Disease

Keywords

Myocardial perfusion; Cardiac Magnetic Resonance; Adenosine

Outcome Measures

Primary Outcomes (1)

• Myocardial hyperemia

  The primary outcome measure is assessed by quantitative myocardial perfusion CMR imaging (ml/min/g).

  During adenosine infusion, 4-6 minutes

Secondary Outcomes (3)

• Heart rate response

  During adenosine infusion, 4-6 minutes

• Blood pressure response

  During adenosine infusion, 4-6 minutes

• Symptoms

  During adenosine infusion, 4-6 minutes

Other Outcomes (4)

• Sex

  In questionnaire obtained approximately 30 minutes before CMR examination

• Age

  In questionnaire obtained approximately 30 minutes before CMR examination

• Ejection fraction

  Measured in the obtained short-axis cine images within approximately 6 months after acquisition

Study Arms (2)

Start standard dose adenosine followed by high dose adenosine

ACTIVE COMPARATOR

Subjects randomized to this arm will undergo the first stress perfusion acquisition with a dose of 140 μg/kg/min adenosine, followed by a second stress perfusion acquisition with the dose of 210 μg/kg/min adenosine.

Drug: Adenosine

Start high dose adenosine followed by standard dose adenosine

ACTIVE COMPARATOR

Subjects randomized to this arm will undergo the first stress perfusion acquisition with a dose of 210 μg/kg/min adenosine, followed by a second stress perfusion acquisition with the dose of 140 μg/kg/min adenosine.

Drug: Adenosine

Interventions

Adenosine DRUG

Standard dose 140 μg/kg/min and high dose 210 μg/kg/min adenosine

Start high dose adenosine followed by standard dose adenosine; Start standard dose adenosine followed by high dose adenosine

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients:
• The subject has given their written consent to participate in the trial.
• Are referred to Department of Clinical Physiology, Skåne University Hospital, for suspected or known CCS or heart failure
• No caffein intake \<24h prior to the examination
• Healthy volunteers:
• The subject has given their written consent to participate in the trial.
• No caffein intake \<24h prior to the examination

You may not qualify if:

• Patients:
• Acute referral (in-house patients)
• Clinically unstable
• Acute chest pain
• Severe or decompensated heart failure
• Non sinus rhythm (e.g. atrial fibrillation)
• Asthma or severe chronic obstructive pulmonary disease
• Known chronic renal failure (eGFR \<45mL/min/1.73m2)
• AV-block II or III
• Left Bundle Branch Block
• Systolic blood pressure \<90 mmHg or \>230 mmHg at rest
• Increased intracranial pressure
• Known allergy or adverse reaction to adenosine or mannitol
• Known allergy or adverse reaction to gadolinium contrast agents
• Treatment with medication containing dipyradimol or teofyllamin/teofyllin

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Clinical Physiology, Department of Clinical Sciences Lund, Lund University, Skåne University Hospital

Lund, Sweden

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia

Interventions

Adenosine

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive 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

Central Study Contacts

Henrik Engblom, MD, PhD

CONTACT

046171000; henrik.engblom@med.lu.se

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The subject will be blinded to the order of adenosine doses.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The subjects will be randomized to start with one of the two adenosine doses, followed by the other dose 10 minutes later during the same examination.

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 29, 2024
• Study Start: October 23, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)