Status:
RECRUITING
Hyperemic mYocardial Perfusion by adEnosine at diffeRent Doses
Lead Sponsor:
Region Skane
Conditions:
Chronic Coronary Syndrome
Coronary Artery Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE4
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 cur...
Eligibility Criteria
Inclusion
- 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
- 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)
- Matches the inclusion criteria for no known heart failure (group b) or known heart failure (group c)
- No caffein intake \<24h prior to the examination
- Healthy volunteers:
- The subject has given their written consent to participate in the trial.
- 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)
- No caffein intake \<24h prior to the examination
Exclusion
- 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
- Claustrophobia
- Devices contraindicated to CMR imaging (pacemaker, implants, intracranial clips etc)
- Pregnancy or breast feeding (screened by question only)
- Inability to give informed consent due to mental state, language difficulties etc
- Healthy volunteers:
- Any of the exclusion criteria for patients
- Blood pressure \> 140/90 measured according to clinical routine
- Known systemic disease
- Known cardiac disease
- Cardiovascular medication
- Medication that might influence cardiovascular health
- Smoking
Key Trial Info
Start Date :
October 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06578234
Start Date
October 23 2024
End Date
December 31 2026
Last Update
June 27 2025
Active Locations (1)
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1
Clinical Physiology, Department of Clinical Sciences Lund, Lund University, Skåne University Hospital
Lund, Sweden