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CupofStress

Evaluating the Impact of Incorrect Preparation for Rubidium-82 PET-CT - The Effect of ‘Improper’ Preparation on Cardiac PET-CT Scan

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON58165
Enrollment
928
Registered
2025-03-24
Start date
2026-02-20
Completion date
Unknown
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease, myocardial ischemia Heart disease caused by coronary atherosclerotic stenosis

Interventions

If the initial scan shows abnormalities, it will be repeated after proper adherence to preparation protocols (abstinence from caffeine, xanthine derivatives, and medications). Patients act as their ow

Sponsors

Spaarne Gasthuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patiënten van 18 tot 80 jaar.Verdenking op ischemisch hartlijden, verwezen voor rubidium-82 myocard perfusie PET-CT met farmacologische stress middels regadenoson.Onvoldoende voorbereiding volgens standaardprotocol (inname van cafeïne, theïne, chocolade, energiedrank, banaan of doorgebruik van medicatie zoals calciumantagonisten, nitraten).In staat en bereid om schriftelijke geïnformeerde toestemming te geven.

Exclusion criteria

Exclusion criteria: Contraindications for regadenoson, such as bronchospastic disease or severe hypotension.Known hypersensitivity or allergy to regadenoson or related substances.Use of theophylline or dipyridamole that cannot be safely discontinued.Simultaneous use of multiple interfering substances (e.g., both caffeine and medication) that prevents reliable interpretation.Pregnant or breastfeeding women.

Design outcomes

Primary

MeasureTime frame
Percentage of normal scans in patients with suboptimal preparation (e.g., intake of caffeine, theine, or medications), indicating that the diagnostic performance of the scan was not compromised.Difference in quantitative myocardial blood flow measurements (stress flow, rest flow, and flow reserve) in patients with abnormal initial scans, comparing the initial scan with the follow-up scan after proper preparation. 

Secondary

MeasureTime frame
Correlation between the estimated amount of caffeine or theine intake (in milligrams, based on standardized values per product) and differences in myocardial blood flow measurements (stress, rest, and flow reserve).Correlation between the time interval between last intake of interfering substances and scan results, assessing whether a shorter abstinence period (e.g., <12 hours) is associated with lower myocardial stress, rest, and flow reserve.Classification of participants into light (0–1 cup/day), moderate (2–3 cups/day), or heavy (>3 cups/day) consumers of caffeine-containing substances. Assessment of variation in myocardial blood flow results across these categoriesIn patients with an initial abnormal Rb-82 PET-CT scan, compare myocardial blood flow parameters (stress, rest, and flow reserve) between the first scan (with continued use of interfering medications such as nitrates or calcium antagonists) and the follow-up scan after proper medication cessation. 

Countries

Netherlands

Contacts

Public ContactJJ Boer

Spaarne Gasthuis

jboer@spaarnegasthuis.nl(023 - 22) 45172

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 14, 2026