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68Ga-NODAGA-RGD PET in Patients With an Occluded Coronary Artery (RGDHeart)

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ClinicalTrials.gov Identifier: NCT04871217
Recruitment Status : Recruiting
First Posted : May 4, 2021
Last Update Posted : May 4, 2021
Sponsor:
Collaborators:
University of Lausanne Hospitals
Leiden University Medical Center
Information provided by (Responsible Party):
Antti Saraste, Turku University Hospital

Brief Summary:

Background: In patients with coronary artery disease, acute or chronic coronary artery occlusion is associated with various degrees of ischemic myocardial injury and left ventricle dysfunction. The integrin αVβ3 plays a role in angiogenesis, i.e. formation of new capillaries from pre-existing blood vessels that is increased during repair of ischemic myocardial injury. 68Ga-NODAGA-RGD is a radiopharmaceutical for positron emission tomography (PET) imaging of αVβ3 integrin expression.

Aim: This study aims at evaluating the feasibility of imaging myocardial αVβ3 integrin expression using 68-Ga-NODAGA-RGD PET and whether 68Ga-NODAGA-RGD uptake is associated with myocardial contractile function in patients with an acute or chronic coronary artery occlusion.

Study design: An academic, prospective, open-label study in 60 patients with an acute or chronic coronary occlusion.

Study population: 30 patients with an ST-elevation acute myocardial infarction weeks and left ventricular ejection fraction <50%. 30 patients with planned percutaneous re-opening of a chronic coronary total occlusion and left ventricular ejection fraction <50%.

Study procedures: Patients will undergo cardiac 68Ga-NODAGA-RGD PET within 3 to 14 days after an ST-elevation acute myocardial infarction or within 4 weeks before and 2 weeks after planned percutaneous re-opening of chronic coronary total occlusion. Myocardial perfusion reserve will be evaluated in patients with chronic total occlusion by PET. Echocardiography will be performed at the time of PET imaging and repeated 6 months later to evaluate global and regional left ventricle contractile function. Data on relevant cardiovascular clinical history and blood sample will be obtained at imaging visits. Cardiac events will be evaluated after two years.

End-points: Primary: Myocardial uptake of 68-Ga-NODAGA-RGD after an acute myocardial infarction or before and after opening of chronic coronary occlusion. Secondary: Global and regional left ventricle systolic function. Blood biomarkers of myocardial injury and heart failure. Myocardial perfusion reserve. Adverse cardiac events including death, myocardial infarction, unstable angina pectoris, repeat revascularization and heart failure hospitalizations.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Diagnostic Test: 68Ga-NODAGA-RGD PET-imaging Not Applicable

Detailed Description:

Background: In patients with coronary artery disease, acute or chronic coronary artery occlusion is associated with various degrees of ischemic myocardial injury and left ventricle dysfunction. The integrin αVβ3 plays a role in angiogenesis (Brooks 1994), i.e. formation of new capillaries from pre-existing blood vessels that is increased during repair of ischemic myocardial injury (Meoli 2004, Higuchi 2008, Sherif 2012, Sun 2003, Jenkins 2017). 68Ga-NODAGA-RGD is a radiopharmaceutical for positron emission tomography (PET) imaging of αVβ3 integrin expression (Grönman 2017, Buchegger 2011, Pohle 2012, Gnesin 2017).

Aim: This study aims at evaluating the feasibility of imaging myocardial αVβ3 integrin expression using 68-Ga-NODAGA-RGD PET and whether 68Ga-NODAGA-RGD uptake is associated with myocardial contractile function in patients with an acute or chronic coronary artery occlusion.

Study design: An investigator-initiated, prospective, open-label study in 60 patients with an acute or chronic coronary occlusion.

Study population: 30 patients with an ST-elevation acute myocardial infarction weeks and left ventricular ejection fraction <50%. 30 patients with planned percutaneous re-opening of a chronic coronary total occlusion and left ventricular ejection fraction <50%.

Study procedures: Patients will undergo cardiac 68Ga-NODAGA-RGD PET within 3 to 14 days after an ST-elevation acute myocardial infarction or within 4 weeks before and 2 weeks after planned percutaneous re-opening of chronic coronary total occlusion. Myocardial perfusion reserve will be evaluated in patients with chronic total occlusion by PET myocardial perfusion imaging. Complete echocardiography will be performed at the time of PET imaging and repeated 6 months later to evaluate global and regional left ventricle contractile function. Data on relevant cardiovascular clinical history and blood sample will be obtained at imaging visits. Cardiac events will be evaluated after two years.

Primary end-point: Myocardial uptake of 68-Ga-NODAGA-RGD after an acute myocardial infarction or before and after opening of chronic coronary occlusion. Secondary end-points: Global and regional left ventricle systolic function. Blood biomarkers of myocardial injury (troponin) and heart failure (pro-BNP). Myocardial perfusion reserve. Adverse cardiac events including death, myocardial infarction, unstable angina pectoris, repeat revascularization and heart failure hospitalizations.

Sample size: This is an exploratory study and formal power calculation cannot be performed.

Ethical aspects: The study conforms to the World Medical Association Declaration of Helsinki. Written statement will be obtained from the ethics committee (the Ethical Board of the South-Western Finland). Permissions from regulatory authorities (the Finnish Medicines Agency Fimea) and the Turku University Hospital for conducting the study will be obtained. Signed and dated informed consent will be obtained from patients before conducting any study specific procedures.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 68Ga-NODAGA-RGD Cardiac PET in Patients With Acute Myocardial Infarction or Chronic Total Coronary Occlusion
Actual Study Start Date : December 4, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acute ST-elevation myocardial infarction or chronic coronary artery occlusion
68-Ga-NODAGA-RGD PET after acute ST-elevation myocardial infarction or before and after re-opening of a chronic coronary artery occlusion
Diagnostic Test: 68Ga-NODAGA-RGD PET-imaging
Patients will undergo cardiac 68Ga-NODAGA-RGD PET in order to detect myocardial αVβ3 integrin expression 3-14 days after an acute myocardial infarction or within 4 weeks before and 2 weeks after re-opening of chronic coronary occlusion. Echocardiography of cardiac function will be performed at the time of PET imaging and repeated 6 months later.




Primary Outcome Measures :
  1. Myocardial uptake of 68Ga-NODAGA-RGD after acute myocardial infarction [ Time Frame: 3 to 14 days after acute myocardial infarction ]
    68Ga-NODAGA-RGD uptake in PET images in the myocardial territory supplied by the occluded coronary artery vs. remote myocardium after an acute myocardial infarction

  2. Myocardial uptake of 68Ga-NODAGA-RGD before and after opening of chronic coronary occlusion [ Time Frame: Within 4 weeks before and 2 weeks after re-opening of a chronic coronary occlusion ]
    Change in 68Ga-NODAGA-RGD uptake in PET images in the myocardial territory supplied by the occluded coronary artery before and after opening of a chronic coronary occlusion


Secondary Outcome Measures :
  1. Global left ventricle systolic function [ Time Frame: At the time of 68Ga-NODAGA-RGD PET imaging and after 6 months of follow-up ]
    Left ventricle ejection fraction (%) assessed by echocardiography

  2. Regional left ventricle systolic function [ Time Frame: At the time of 68Ga-NODAGA-RGD PET imaging and after 6 months of follow-up ]
    Regional myocardial strain (%) assessed by echocardiography

  3. Myocardial perfusion reserve [ Time Frame: At the time of 68Ga-NODAGA-RGD PET imaging within 4 weeks before and 2 weeks after re-opening of a chronic coronary occlusion ]
    Assessed by PET myocardial perfusion imaging before and after re-opening of chronic coronary occlusion

  4. Adverse cardiac events [ Time Frame: After 2 years of follow-up ]
    Number of patients with myocardial infarction, unstable angina pectoris, repeat revascularization, heart failure hospitalization or death

  5. Blood biomarker of heart failure [ Time Frame: At the time of 68Ga-NODAGA-RGD PET imaging and after 6 months of follow-up ]
    pro-BNP (ng/L)

  6. Blood biomarker of myocardial injury [ Time Frame: At the time of 68Ga-NODAGA-RGD PET imaging and after 6 months of follow-up ]
    Cardiac troponin T (ng/L)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ST-elevation acute myocardial infarction within 3-14 days
  • Planned elective percutaneous revascularization of angiographically documented coronary chronic total occlusion (CTO)
  • Left ventricular ejection fraction < 50% when hospitalized for index acute myocardial infarction or within 12 months before planned revascularization of coronary CTO
  • Provision of signed and dated informed consent prior to study specific procedures

Exclusion Criteria:

  • Current unstable angina
  • Significant valvular heart disease
  • NYHA IV heart failure symptoms
  • Severe untreated hypertension (>180/110 mmHg)
  • Female not post-menopausal
  • Contraindications for adenosine infusion (in patients with CTO):
  • Severe renal failure (estimated glomerular filtration rate < 30 ml/min)
  • Atrial fibrillation with ventricular response > 110 bpm
  • No acoustic window for left ventricle assessment by echocardiography
  • Previous cardiac surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04871217


Contacts
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Contact: Antti Saraste, MD, PhD +35823130000 antti.saraste@utu.fi

Locations
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Finland
Turku University Hospital Recruiting
Turku, Finland, 20520
Contact: Antti Saraste, MD, PhD    +3582313000    antti.saraste@utu.fi   
Sub-Investigator: Christian Paunonen, BM         
Sub-Investigator: Juhani Knuuti, MD, PhD         
Netherlands
Leiden Medical Center Active, not recruiting
Leiden, Netherlands
Switzerland
University of Lausanne Hospitals Recruiting
Lausanne, Switzerland, CH-1011
Contact: John Prior, MD, PhD         
Sponsors and Collaborators
Turku University Hospital
University of Lausanne Hospitals
Leiden University Medical Center
Investigators
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Principal Investigator: Antti Saraste, MD, PhD Turku University Hospital
Publications:

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Responsible Party: Antti Saraste, MD, PhD, Turku University Hospital
ClinicalTrials.gov Identifier: NCT04871217    
Other Study ID Numbers: T02/011/18
First Posted: May 4, 2021    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: May be shared upon reasonable request to the PI

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Antti Saraste, Turku University Hospital:
Positron Emission Tomography
Myocardial Infarction
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases