This is a unblinded Phase 3 multicenter study, investigating the diagnostic properties of 15O-H2O PET MPI in patients with suspected ischemic heart disease .
- Conditions
- Coronary Artery DiseaseMedDRA version: 20.0Level: LLTClassification code 10006896Term: CADSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2021-006295-17-DK
- Lead Sponsor
- MedTrace Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 215
1.Male and female subjects =18 years;
2.Informed consent form (ICF) read, signed, and dated prior to any study procedures being performed;
3.Subjects who fall into any one of the following categories:
a)Have been referred for an ICA directly 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 assessment was performed.
c)Had a CCTA with normal coronaries or minimal CAD (Less than < 20% stenosis).
The PET 15O-H2O study and ICA or CCTA testing need to be completed within a 30-day window, with time 0 defined as the date of the first of
these three tests, or the screening visit for Pathway 1.
4.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 on the day of drug administration) must be negative;
these patients 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.
5.Male will need to use contraceptive methods until end of the follow-up period.
6.Patients are able to comply with all study procedures as described in the protocol.
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 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 85
1.Subjects are unable to undergo (even partially) any of the imaging procedures;
2.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
3.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.
d. moderate or sever aortic or mitral stenosis or regurgitation.
4.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).
5.Subjects who are on sildenafil (Viagra) or oral dipyridamole (Persantine, Aggrenox) therapy and for
whom its use cannot be terminated or suspended for =24 hours prior to treatment of study drug.
6.Subjects with significant co-morbidities that would prevent appropriate completion of the
protocol procedures.
7.Subjects who have participated in another research study using investigational drugs within the 30
days prior to enrollment (Day 0) or through the duration of the trial (subjects in observational studies with approved agents and
subjects known to be on placebo may be enrolled).
8.Subjects who have previously participated in this study.
9.Subjects with a close affiliation with the investigational site, defined as a close relative to the
Investigator, or a dependent person such as an employee, student or intern at the investigational
site.
10.Subjects scheduled for, or planning to undergo, any interventional cardiac procedures between enrolment and ICA (pathway 1) signing of informed consent (IC) or enrolment and 15O-H2O
PET MPI (pathway 2 and 3)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method