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New cardiac imaging biomarker for assessment of patients with acute or chronic occlusion of a coronary artery

68Ga-NODAGA-RGD cardiac PET in patients with acute myocardial infarction or chronic total coronary occlusion

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2014-004392-23-FI
Enrollment
60
Registered
2018-01-22
Start date
2018-02-08
Completion date
Unknown
Last updated
2024-11-04

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

Conditions

Acute or chronic coronary artery occlusion

Interventions

Product Name: 68Ga-NODAGA-RGD Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: 68Ga-NODAGA-RGDyK Other descriptive name: 68GA-NODAGA-RGD Concentration unit: % percent Concentr

Sponsors

Turku University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Acute ST-elevation myocardial infarction within 3-14 days or planned percutaneous intervention of chronic coronary artery occlusion within 4 weeks 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: Age 180/110 mmHg), female not post-menopausal, severe renal failure (GFR < 30 ml/min), severe tachyarrhythmias, previous cardiac surgery

Design outcomes

Primary

MeasureTime frame
Main Objective: Evaluate PET imaging with 68Ga-NODAGA-RGD in patients with acute or chronic coronary artery occlusion;Secondary Objective: Study relationship between 68Ga-NODAGA-RGD uptake and contractile function of the myocardium supplied by occluded coronary artery;Primary end point(s): 68Ga-NODAGA-RGD tracer uptake in PET images in the myocardium supplied by an occluded coronary artery ;Timepoint(s) of evaluation of this end point: 3 to 14 days after acute coronary artery occlusion or within 4 weeks before and 2 weeks after planned percutaneous intervention of chronic coronary occlusion

Secondary

MeasureTime frame
Secondary end point(s): Regional myocardial contractile function assessed by echocardiography;Timepoint(s) of evaluation of this end point: At the time of PET imaging with 68Ga-NODAGA-RGD and 6 months after PET with 68Ga-NODAGA-RGD

Countries

Finland, Switzerland

Contacts

Public ContactTurku University Hospital

Turku University Hospital

antti.saraste@utu.fi

Outcome results

None listed

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