68 Ga-NODAGA-E[c(RGDγK)]2: Positron Emission Tomography Tracer for Imaging of Angiogenesis in Ischemic Heart Disease

NCT ID: NCT03505346

Last Updated: 2023-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-12-01

Brief Summary

The aim is to examine the expression of αvβ3 integrin using a novel selective radiotracer in patients with chronich ischemic heart disease and investigate if it is a suitable tool for predicting myocardial recovery and thus prognosis after intervention.

Detailed Description

Ischemic heart disease is worldwide the single most frequent cause of death. The number of patients surviving acute myocardial injury is increasing due to improved acute treatment. However, after the initial repair, the tissue undergoes a remodeling phase to compensate for the damaged area. This re-modeling phase can change the structure end geometry of the heart resulting in lower ejection fraction, leading to cardiac dysfunction, which eventually leads to heart failure. Ischemic heart disease is most commently caused by arteriosclerosis of the coronary artery.

If chronic ischemic heart disease is left untreated, it will lead to symptoms to the patient. These symptons occur when the myocardiel oxygen demand exceeds the oxygen provided, due to coronary occlusion.

If the heart suffers from ischemia, the tissue reacts strongly to the hypoxia. The body will as a compensatory mechanism create new vessel to provide the tissue with oxygen. This is known as the biological process of angiogenesis. This complex process involves different angiogenic and pro-fibrotic transcription factors that initiate the restoration of capillaries by sprouting from the existing endothelial cells in response to hypoxia.

Integrin αvβ3 is a transmembrane cell surface receptor that is markedly upregulated in states of angiogenesis. It facilitates migration and proliferation and thereby allowing cells to respond to extracellular environment. Integrin αvβ3 is thus a key player in the angiogenic process. The integrin αvβ3 has a binding site for an RGD peptide (Arg-Gly-Asp motif) and this can be targeted by PET tracers.

RGD-based PET tracers have been shown to accumulate at the site of myocardial necrosis in both human and animal studies. The uptake before interventions may correlate to recovery of cardiac function and thus serve as a prognostic marker after intervention.

Conditions

Chronic Ischemic Heart Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

percutanous coronary intervention(PCI)

200 MBq 68Ga-NODAGA-E\[c(RGDyK)\]2 administered IV. two times. 14-21 days before intervention and 30-35 days after intervention

Group Type: EXPERIMENTAL

68Ga-NODAGA-E[c(RGDyK)]2

Intervention Type: DRUG

200 MBq 68Ga-NODAGA-E\[c(RGDyK)\]2 administered IV.

Coronary artery bypass-graft(CABG)

200 MBq 68Ga-NODAGA-E\[c(RGDyK)\]2 administered IV. two times. 14-21 days before intervention and 30-35 days after interventionintervention

Group Type: EXPERIMENTAL

68Ga-NODAGA-E[c(RGDyK)]2

Intervention Type: DRUG

200 MBq 68Ga-NODAGA-E\[c(RGDyK)\]2 administered IV.

Interventions

68Ga-NODAGA-E[c(RGDyK)]2

200 MBq 68Ga-NODAGA-E\[c(RGDyK)\]2 administered IV.

Intervention Type: DRUG

Other Intervention Names

RGD-PET

Eligibility Criteria

Inclusion Criteria

• Age over 50 years
• Patient with known chornic ischemic Heart disease admitted to Rigshospitalet to either PCI og CABG

Exclusion Criteria

• No prior history of Heart surgery
• Not treated with anti-angiogenic medicine
• Subject with pacemaker, cochlear implant or insulin pump
• Pregnancy
• Lactation
• Severe claustrophobia
• Severe obesity (weight above 140kg)
• Conversion from PCI to CABG
• If a subject is in the fertile age, a pregnancy test will be use prior to injection to the PET_tracer
• If a subject is having a severe allergic reaction to the PET-tracer, the person will be excluded for the rest of the trial
• If the PET-tracer is administered subcutaneous, the person will be excluded for the rest of the trial¨
• Type I or II diabetes

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Simon Bentsen

Medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreas Kjær, MD

Role: STUDY_DIRECTOR

Rigshospitalet, Denmark

Locations

Department of Physiology, Nuclear Medicine and PET

Copenhagen, Capital Region, Denmark

Countries

Denmark

Central Contacts

Simon Bentsen, MD

Role: CONTACT

simon.bentsen.01@regionh.dk

+4535451793

Rasmus Ripa, MD

Role: CONTACT

rasmus.ripa@regionh.dk

+4535454011

Other Identifiers

EUDRA-CT: 2017-002712-14

Identifier Type: -

Identifier Source: org_study_id