Clinical trial NCT06578234: Hyperemic mYocardial Perfusion by adEnosine at diffeRent Doses
Official title: Hyperemic mYocardial Perfusion by adEnosine at diffeRent Doses
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Chronic Coronary Syndrome
Coronary Artery Disease
Ischemic Heart Disease
Keywords: Myocardial perfusion
Cardiac Magnetic Resonance
Adenosine
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 180
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Myocardial hyperemia
timeFrame: During adenosine infusion, 4-6 minutes
Secondary outcomes:
measure: Heart rate response
timeFrame: During adenosine infusion, 4-6 minutes
measure: Blood pressure response
timeFrame: During adenosine infusion, 4-6 minutes
measure: Symptoms
timeFrame: During adenosine infusion, 4-6 minutes
Other outcomes:
measure: Sex
timeFrame: In questionnaire obtained approximately 30 minutes before CMR examination
measure: Age
timeFrame: In questionnaire obtained approximately 30 minutes before CMR examination
measure: Ejection fraction
timeFrame: Measured in the obtained short-axis cine images within approximately 6 months after acquisition
measure: Serum-caffeine
timeFrame: Blood samples are analysed within 9 months
Locations:
city: Lund
country: Sweden
facility: Clinical Physiology, Department of Clinical Sciences Lund, Lund University, Skåne University Hospital
Study officials:
References: