Hyperemic mYocardial Perfusion by adEnosine at diffeRent Doses

Hyperemic mYocardial Perfusion by adEnosine at diffeRent Doses (NCT06578234) is a Phase 4 interventional studying Chronic Coronary Syndrome and Coronary Artery Disease, sponsored by Region Skane. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 180 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Chronic Coronary Syndrome subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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 willing to sign a consent form 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Adenosine

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Clinical Physiology, Department of Clinical Sciences Lund, Lund University, Skåne University Hospital

Lund, Sweden

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06578234), the sponsor (Region Skane), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06578234 clinical trial studying?

Who can participate in NCT06578234?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06578234?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06578234. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06578234. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.