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A Phase 3, Multicenter, Open Label Study to Confirm the Diagnostic Potential of Intravenously Administered 15O- H2O to Identify Coronary Artery Disease During Pharmacological Stress and Resting Conditions Using PET Imaging
EU CTIS ID: 2023-503843-33-00
What this study is testing
Determine the sensitivity and specificity of the 15O-H2O positron emission tomography (PET) myocardial perfusion imaging (MPI) to detect coronary artery disease (CAD) using the truth-standard of invasive coronary angiogram (ICA) with fractional flow reserve (FFR) or instantaneous wave-Free Ration (iFR) coronary computed tomography angiogram (CCTA).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male and female subjects ≥18 years;
- Informed consent form (ICF) read, signed, and dated prior to any study procedures being performed;
- Subjects who fall into any one of the following categories: a. Have been referred for an ICA directly or after non-invasive testing (e.g., SPECT or PET MPI, stress echo, CCTA, ETT). b. Had an ICA with no intervention. However, if any stenosis ≥40% but ≤70% was observed, an FFR or iFR assessment must have been performed. c. Had a CCTA with normal coronaries or minimal CAD (< 25% stenosis).
- Women of Child Bearing Potential (WOCBP) must be non-pregnant, and non-lactating. For women of childbearing potential, the results of a urine human chorionic gonadotropin (HCG) pregnancy test (with the result known prior to drug administration) must be negative; these subjects must be practicing appropriate birth control from time of the screening until end of the follow-up period. For women who are either surgically sterile (have a documented bilateral tubal ligation or oophorectomy and/or hysterectomy) or are post-menopausal (cessation of menses for more than 1 year), enrollment in the study without a pregnancy test at screening is allowed.
- Male study subjects must use contraceptive methods until end of the follow-up period.
- Subjects are able to comply with all study procedures as described in the protocol.
You likely can't join if
- Subjects are unable to undergo (even partially) any of the imaging procedures;
- Subjects scheduled for, or planning to undergo, any interventional cardiac procedures between enrollment and ICA (pathway 1) or signing of informed consent and 15O-H2O PET MPI (pathway 2 and 3)
- Subjects with a known history of cardiac disease including: a. myocardial infarction, previous coronary revascularization, or chronic ischemic cardiomyopathy b. primary myocardial disease such as cardiac amyloidosis or hypertrophic cardiomyopathy c. known left ventricular dysfunction d. moderate or severe aortic or mitral stenosis or regurgitation
- Subjects in whom adenosine stress testing is contraindicated, including but not limited to: a. Subjects with severe COPD or chronic asthma. b. Subjects with second- or third-degree atrioventricular block without a pacemaker.
- Subjects with claustrophobia to an extent that would limit their ability to undergo PET imaging (subjects whose claustrophobia is known to be readily controlled with drugs or psychological support may be enrolled).
- Subjects who are on sildenafil (Viagra), oral dipyridamole (Persantine, Aggrenox) therapy or subjects on any PDE5 inhibitor (i.e. tadalafil, avanafil, vardenafil), and for whom its use cannot be terminated or suspended for at least 5 half-lives prior to treatment of study drug..
See the full eligibility criteria
Who can join
- Male and female subjects ≥18 years;
- Informed consent form (ICF) read, signed, and dated prior to any study procedures being performed;
- Subjects who fall into any one of the following categories: a. Have been referred for an ICA directly or after non-invasive testing (e.g., SPECT or PET MPI, stress echo, CCTA, ETT). b. Had an ICA with no intervention. However, if any stenosis ≥40% but ≤70% was observed, an FFR or iFR assessment must have been performed. c. Had a CCTA with normal coronaries or minimal CAD (< 25% stenosis).
- Women of Child Bearing Potential (WOCBP) must be non-pregnant, and non-lactating. For women of childbearing potential, the results of a urine human chorionic gonadotropin (HCG) pregnancy test (with the result known prior to drug administration) must be negative; these subjects must be practicing appropriate birth control from time of the screening until end of the follow-up period. For women who are either surgically sterile (have a documented bilateral tubal ligation or oophorectomy and/or hysterectomy) or are post-menopausal (cessation of menses for more than 1 year), enrollment in the study without a pregnancy test at screening is allowed.
- Male study subjects must use contraceptive methods until end of the follow-up period.
- Subjects are able to comply with all study procedures as described in the protocol.
What rules you out
- Subjects are unable to undergo (even partially) any of the imaging procedures;
- Subjects scheduled for, or planning to undergo, any interventional cardiac procedures between enrollment and ICA (pathway 1) or signing of informed consent and 15O-H2O PET MPI (pathway 2 and 3)
- Subjects with a known history of cardiac disease including: a. myocardial infarction, previous coronary revascularization, or chronic ischemic cardiomyopathy b. primary myocardial disease such as cardiac amyloidosis or hypertrophic cardiomyopathy c. known left ventricular dysfunction d. moderate or severe aortic or mitral stenosis or regurgitation
- Subjects in whom adenosine stress testing is contraindicated, including but not limited to: a. Subjects with severe COPD or chronic asthma. b. Subjects with second- or third-degree atrioventricular block without a pacemaker.
- Subjects with claustrophobia to an extent that would limit their ability to undergo PET imaging (subjects whose claustrophobia is known to be readily controlled with drugs or psychological support may be enrolled).
- Subjects who are on sildenafil (Viagra), oral dipyridamole (Persantine, Aggrenox) therapy or subjects on any PDE5 inhibitor (i.e. tadalafil, avanafil, vardenafil), and for whom its use cannot be terminated or suspended for at least 5 half-lives prior to treatment of study drug..
- Subjects with significant co-morbidities that would prevent appropriate completion of the protocol procedures.
- Subjects who have participated in another research study using investigational drugs within the 30 days prior to enrollment or through the duration of the trial (subjects in observational studies with approved agents and subjects known to be on placebo may be enrolled).
- Subjects who have previously participated in this study.
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.