Investigating different doses of adenosine for heart imaging

Hyperemic mYocardial Perfusion by adEnosine at diffeRent Doses

This study tests whether different doses of adenosine can improve heart imaging for people suspected of having chronic coronary syndrome.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Region Skane (Academic / other)
• Locations: 1 site (Lund)
• Trial ID: NCT06578234 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness of varying doses of adenosine, a pharmaceutical stressor, during cardiac magnetic resonance examinations for patients with suspected chronic coronary syndrome. The study compares a standard dose of 140 micrograms/kg/min to a higher dose of 210 micrograms/kg/min to determine which induces a better hyperemic response. By improving the diagnostic accuracy of adenosine as a stressor, the trial aims to enhance treatment decisions and patient outcomes for those with chronic coronary syndrome. Participants will include both patients with suspected heart conditions and healthy volunteers, ensuring a diverse age and sex representation.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 40 and older with suspected or known chronic coronary syndrome or heart failure, who meet specific inclusion criteria.

Not a fit: Patients who are acutely unstable, experiencing chest pain, or have severe heart failure may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate diagnoses and improved treatment strategies for patients with chronic coronary syndrome.

How similar studies have performed: Previous studies have indicated that varying doses of adenosine may improve diagnostic outcomes, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

Patients:

1. The subject has given their written consent to participate in the trial.
2. Are referred to Department of Clinical Physiology, Skåne University Hospital, for suspected or known CCS or heart failure
3. Matches the inclusion criteria for sex and age (6 females and 6 males from each group in each age decade from 40 to \>80 years old)
4. Matches the inclusion criteria for no known heart failure (group b) or known heart failure (group c)
5. No caffein intake \<24h prior to the examination

Healthy volunteers:

1. The subject has given their written consent to participate in the trial.
2. Matches the inclusion criteria for sex and age (6 females and 6 males from each group in each age decade from 40 to \>80 years old)
3. No caffein intake \<24h prior to the examination

Exclusion Criteria:

Patients:

1. Acute referral (in-house patients)
2. Clinically unstable
3. Acute chest pain
4. Severe or decompensated heart failure
5. Non sinus rhythm (e.g. atrial fibrillation)
6. Asthma or severe chronic obstructive pulmonary disease
7. Known chronic renal failure (eGFR \<45mL/min/1.73m2)
8. AV-block II or III
9. Left Bundle Branch Block
10. Systolic blood pressure \<90 mmHg or \>230 mmHg at rest
11. Increased intracranial pressure
12. Known allergy or adverse reaction to adenosine or mannitol
13. Known allergy or adverse reaction to gadolinium contrast agents
14. Treatment with medication containing dipyradimol or teofyllamin/teofyllin
15. Claustrophobia
16. Devices contraindicated to CMR imaging (pacemaker, implants, intracranial clips etc)
17. Pregnancy or breast feeding (screened by question only)
18. Inability to give informed consent due to mental state, language difficulties etc

Healthy volunteers:

1. Any of the exclusion criteria for patients
2. Blood pressure \> 140/90 measured according to clinical routine
3. Known systemic disease
4. Known cardiac disease
5. Cardiovascular medication
6. Medication that might influence cardiovascular health
7. Smoking

Where this trial is running

Lund

• Clinical Physiology, Department of Clinical Sciences Lund, Lund University, Skåne University Hospital — Lund, Sweden (Recruiting)

Study contacts

• Study coordinator: Henrik Engblom, MD, PhD

Conditions Chronic Coronary Syndrome; Coronary Artery Disease; Ischemic Heart Disease; Myocardial perfusion; Cardiac Magnetic Resonance; Adenosine