E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cardiac amyloidosis |
Sydämen amyloidoosi |
|
E.1.1.1 | Medical condition in easily understood language |
Protein accumulation disease of the heart causing "stiff heart syndrome" |
Proteiininen kertymäsairaus sydänlihakseen (amyloidoosi), joka aiheuttaa jäykän sydämen oireyhtymän |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10007509 |
E.1.2 | Term | Cardiac amyloidosis |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
In this study we evaluate the diagnostic use of flutemetamol (Vizamyl) radioactive positron emission tomography (PET) imaging agent in the detection of cardiac amyloid disease. Vizamyl is a derivate of Thioflavin-T which is used for dying amyloid proteins for microscopy. Vizamyl is accepted for clinical use in the imaging of amyloid deposits of the brain |
Tutkimuksessamme arvioimme flutemetamol-merkkiaineen (Vizamyl) tarkuutta sydämen amyloidoosin positroniemissiotomografiakuvantamisessa (PET). Vizamyl on kehitetty mikroskooppiväriaine Tioflaviini-T:n pohjalta, jota on käytetty amyloidisäikeiden värjäämiseen. Vizamyl on aiemmin hyväksytty kliiniseen käyttöön aivojen amyloidisäikeiden toteamisessa PET-kuvantamisella. |
|
E.2.2 | Secondary objectives of the trial |
We evaluate the possibility of noninvasive detection of different subclasses of amyloid diseases by PET imaging of signal intensity of Vizamyl |
Pyrimme kajoamattomasti tyypittämään PET-kuvantamisen avulla eri amyloidisairauden alatyyppejä. Erilaiset amyloidiproteiinit oletettavasti kuvautuvat eri tavoin PET-kuvauksessa. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Known diagnosis of cardiac amyloidosis or previously excluded cardiac amyloidosis (myocardial biopsy or non-invasive imaging). |
Tiedossa oleva sydänamyloidoosi tai aikaisemmin poissuljettu sydänamyloidoosi (sydänlihaksen biopsia tai kajoamaton kuvantaminen) |
|
E.4 | Principal exclusion criteria |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Total mortality |
Kokonaiskuolleisuus |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1,3 and 5 years |
1,3 ja 5 vuotta |
|
E.5.2 | Secondary end point(s) |
New diagnosis of heart failure Heart failure hospitalization |
Uusi sydämen vajaatoiminnan diagnoosi Hospitalisaatio sydämen vajaatoiminnan vuoksi
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1,3 and 5 years |
1,3 ja 5 vuotta |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
We collect safety data to demonstrate safety of Vizamyl in cardiac population as this not been systematically reported previously. However, safety of Vizamyl is well established in both clinical use and previous clinical trials including also elderly patients. |
Raportoimme turvallisuusdataa, vaikka Vizamylin turvallisuus on tunnettu sekä kliinisen työn että aikaisempien tutkimusten perusteella. Turvallisuusdataa ei ole kuitenkaan systemaattisesti raportoitu sydänpotilaiden tutkimuspopulaatiossa. Sen raportointu voi jatkossa auttaa kuvantamisindikaation laajentamisessa sydänkuvantamiseen. Pääasiallinen tutkimuslähtökohtamme ja painotuksemme on kuitenkin diagnostinen. Vizamyl-annos ei poikkea tavanomaisesta PET-kuvauksesta. Vain kuvauskohde eroaa. |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last follow-up data collected at 5 year time-point |
Viimeinen seurantadata on kerätty (5 vuoden aikapisteessä) |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |