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

Phase 1

Conditions: Acute or chronic coronary artery occlusion
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

Registration Number: EUCTR2014-004392-23-FI

Lead Sponsor: Turku University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 60

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

Age <18 or = 85 years, current unstable angina pectoris, significant valvular heart disease, NYHA IV heart failure symptoms, severe untreated hypertension (>180/110 mmHg), female not post-menopausal, severe renal failure (GFR < 30 ml/min), severe tachyarrhythmias, previous cardiac surgery

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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