Hyperemic mYocardial Perfusion by adEnosine at diffeRent Doses

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-23

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Coronary Syndrome Coronary Artery Disease Ischemic Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

The subject will be blinded to the order of adenosine doses.

Study Groups

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Start standard dose adenosine followed by high dose adenosine

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.

Group Type ACTIVE_COMPARATOR

Adenosine

Intervention Type DRUG

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

Start high dose adenosine followed by standard dose adenosine

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.

Group Type ACTIVE_COMPARATOR

Adenosine

Intervention Type DRUG

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

Interventions

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Adenosine

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

Intervention Type DRUG

Eligibility Criteria

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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
5. No caffein intake \<24h prior to the examination

Healthy volunteers:

1. The subject has given their written consent to participate in the trial.
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:

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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes