Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-03 @ 6:58 PM
Study NCT ID:
NCT06578234
Status:
RECRUITING
Last Update Posted:
2025-06-27
First Post:
2024-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyperemic mYocardial Perfusion by adEnosine at diffeRent Doses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000241', 'term': 'Adenosine'}], 'ancestors': [{'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The subject will be blinded to the order of adenosine doses.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2024-08-15', 'studyFirstSubmitQcDate': '2024-08-27', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sex', 'timeFrame': 'In questionnaire obtained approximately 30 minutes before CMR examination', 'description': 'The association between sex (female and male) and adenosine response'}, {'measure': 'Age', 'timeFrame': 'In questionnaire obtained approximately 30 minutes before CMR examination', 'description': 'The association between age (years) and adenosine response'}, {'measure': 'Ejection fraction', 'timeFrame': 'Measured in the obtained short-axis cine images within approximately 6 months after acquisition', 'description': 'The association between ejection fraction (%) assessed from CMR images and adenosine response'}, {'measure': 'Serum-caffeine', 'timeFrame': 'Blood samples are analysed within 9 months', 'description': 'The association between serum caffeine levels (mg/L) assessed from blood samples and adenosine response'}], 'primaryOutcomes': [{'measure': 'Myocardial hyperemia', 'timeFrame': 'During adenosine infusion, 4-6 minutes', 'description': 'The primary outcome measure is assessed by quantitative myocardial perfusion CMR imaging (ml/min/g).'}], 'secondaryOutcomes': [{'measure': 'Heart rate response', 'timeFrame': 'During adenosine infusion, 4-6 minutes', 'description': 'Compare heart rate (beat/min) at standard and high dose adenosine'}, {'measure': 'Blood pressure response', 'timeFrame': 'During adenosine infusion, 4-6 minutes', 'description': 'Compare systolic blood pressure (mmHg) at standard and high dose adenosine'}, {'measure': 'Symptoms', 'timeFrame': 'During adenosine infusion, 4-6 minutes', 'description': 'Compare presence of symptoms (evaluated using a Borg10-scale) at standard and high dose adenosine'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myocardial perfusion', 'Cardiac Magnetic Resonance', 'Adenosine'], 'conditions': ['Chronic Coronary Syndrome', 'Coronary Artery Disease', 'Ischemic Heart Disease']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients:\n\n1. The subject has given their written consent to participate in the trial.\n2. Are referred to Department of Clinical Physiology, Skåne University Hospital, for suspected or known CCS or heart failure\n3. 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)\n4. Matches the inclusion criteria for no known heart failure (group b) or known heart failure (group c)\n5. No caffein intake \\<24h prior to the examination\n\nHealthy volunteers:\n\n1. The subject has given their written consent to participate in the trial.\n2. 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)\n3. No caffein intake \\<24h prior to the examination\n\nExclusion Criteria:\n\nPatients:\n\n1. Acute referral (in-house patients)\n2. Clinically unstable\n3. Acute chest pain\n4. Severe or decompensated heart failure\n5. Non sinus rhythm (e.g. atrial fibrillation)\n6. Asthma or severe chronic obstructive pulmonary disease\n7. Known chronic renal failure (eGFR \\<45mL/min/1.73m2)\n8. AV-block II or III\n9. Left Bundle Branch Block\n10. Systolic blood pressure \\<90 mmHg or \\>230 mmHg at rest\n11. Increased intracranial pressure\n12. Known allergy or adverse reaction to adenosine or mannitol\n13. Known allergy or adverse reaction to gadolinium contrast agents\n14. Treatment with medication containing dipyradimol or teofyllamin/teofyllin\n15. Claustrophobia\n16. Devices contraindicated to CMR imaging (pacemaker, implants, intracranial clips etc)\n17. Pregnancy or breast feeding (screened by question only)\n18. Inability to give informed consent due to mental state, language difficulties etc\n\nHealthy volunteers:\n\n1. Any of the exclusion criteria for patients\n2. Blood pressure \\> 140/90 measured according to clinical routine\n3. Known systemic disease\n4. Known cardiac disease\n5. Cardiovascular medication\n6. Medication that might influence cardiovascular health\n7. Smoking'}, 'identificationModule': {'nctId': 'NCT06578234', 'acronym': 'HYPER', 'briefTitle': 'Hyperemic mYocardial Perfusion by adEnosine at diffeRent Doses', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'Hyperemic mYocardial Perfusion by adEnosine at diffeRent Doses', 'orgStudyIdInfo': {'id': '2023-505248-20-00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Start standard dose adenosine followed by high dose adenosine', 'description': '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.', 'interventionNames': ['Drug: Adenosine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Start high dose adenosine followed by standard dose adenosine', 'description': '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.', 'interventionNames': ['Drug: Adenosine']}], 'interventions': [{'name': 'Adenosine', 'type': 'DRUG', 'description': 'Standard dose 140 μg/kg/min and high dose 210 μg/kg/min adenosine', 'armGroupLabels': ['Start high dose adenosine followed by standard dose adenosine', 'Start standard dose adenosine followed by high dose adenosine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lund', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Henrik Engblom, Professor, MD', 'role': 'CONTACT', 'phone': '046171000'}], 'facility': 'Clinical Physiology, Department of Clinical Sciences Lund, Lund University, Skåne University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'centralContacts': [{'name': 'Henrik Engblom, MD, PhD', 'role': 'CONTACT', 'email': 'henrik.engblom@med.lu.se', 'phone': '046171000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}