Comparison of two medicines in heartr perfusion stress studies.

Quantitative myocardial perfusion response to adenosine and regadenoson in patients with suspected coronary artery disease - RegWater

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001225-11-FI

Enrollment

Registered

2013-05-13

Start date

2013-08-09

Completion date

Unknown

Last updated

2014-01-27

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

Conditions

Coronary artery desease MedDRA version: 14.1 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: Adenocor Product Name: Adenocor Pharmaceutical Form: Injection Other descriptive name: ADENOSINE Trade Name: Rapiscan Product Name: Rapidcan Pharmaceutical Form: Injection CAS Number: 313

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: One of the following: Age 18-80 Suspected CAD and referred for cardiac PET perfusion imaging based on clinical indications Known CAD and referred for cardiac PET perfusion imaging based on clinical indications Patients have been or are referred for coronary angiography, either noninvasive or invasive Informed consent from the patient Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7

Exclusion criteria

Exclusion criteria: Continuing, uncontrolled unstable angina symptoms or urgent CABG after invasive coronary angiography ST-elevation myocardial infarction (STEMI) EF 180/110 mmHg) Moderate to severe renal failure Women with childbearing potential Age 80 years Unstable asthma II or III degree AV block or sick sinus syndrome without pacemaker Severe hypotension (systolic bloodpressure < 90 mmHg), Allergy to x-ray contrast agents (patients have also angiography)

Design outcomes

Primary

Measure	Time frame
Main Objective: Aim of the present study is to directly compare the quantitative flow responses or Regadenoson against adenosine using cardiac O-15-water PET imaging in patients with suspected or known CAD. The study will provide information on whether: 1) Regadenoson induces similar quantitative increase in myocardial perfusion than adenosine 2) The ischemic and non-ischemic regions have similar response to Regadenoson than to adenosine.;Secondary Objective: We will find out weather similar absolute perfusion cut-off values can be used for diagnostic purposes. ;Primary end point(s): The reaction of heart´s perfusion to the medications. ;Timepoint(s) of evaluation of this end point: 20min	—

Measure

Time frame

Main Objective: Aim of the present study is to directly compare the quantitative flow responses or Regadenoson against adenosine using cardiac O-15-water PET imaging in patients with suspected or known CAD. The study will provide information on whether: 1) Regadenoson induces similar quantitative increase in myocardial perfusion than adenosine 2) The ischemic and non-ischemic regions have similar response to Regadenoson than to adenosine.;Secondary Objective: We will find out weather similar absolute perfusion cut-off values can be used for diagnostic purposes. ;Primary end point(s): The reaction of heart´s perfusion to the medications. ;Timepoint(s) of evaluation of this end point: 20min

—

Secondary

Measure	Time frame
Secondary end point(s): The cut off values of Regadenoson.;Timepoint(s) of evaluation of this end point: 20min	—

Countries

Finland

Contacts

Public ContactTurku University Hospital

Turku University Hospital

esanra@utu.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026