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

March 20, 2022 updated by: Antti Saraste, Turku University Hospital

68Ga-NODAGA-RGD Cardiac PET in Patients With Acute Myocardial Infarction or Chronic Total Coronary Occlusion

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Finland
      • Turku, Finland, 20520
        • Recruiting
        • Turku University Hospital
        • Contact:
        • Sub-Investigator:
          • Christian Paunonen, BM
        • Sub-Investigator:
          • Juhani Knuuti, MD, PhD
  • Netherlands
      • Leiden, Netherlands
        • Active, not recruiting
        • Leiden Medical Center
  • Switzerland
      • Lausanne, Switzerland, CH-1011
        • Recruiting
        • University of Lausanne Hospitals
        • Contact:
          • John Prior, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 to 14 days after acute myocardial infarction
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
Within 4 weeks before and 2 weeks after re-opening of a chronic coronary occlusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At the time of 68Ga-NODAGA-RGD PET imaging and after 6 months of follow-up
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
At the time of 68Ga-NODAGA-RGD PET imaging and after 6 months of follow-up
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
At the time of 68Ga-NODAGA-RGD PET imaging within 4 weeks before and 2 weeks after re-opening of a chronic coronary occlusion
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
After 2 years of follow-up
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)
At the time of 68Ga-NODAGA-RGD PET imaging and after 6 months of follow-up
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)
At the time of 68Ga-NODAGA-RGD PET imaging and after 6 months of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Collaborators

University of Lausanne Hospitals
Leiden University Medical Center

Investigators

  • Principal Investigator: Antti Saraste, MD, PhD, Turku University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2018

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

January 14, 2021

First Submitted That Met QC Criteria

May 3, 2021

First Posted (Actual)

May 4, 2021

Study Record Updates

Last Update Posted (Actual)

March 22, 2022

Last Update Submitted That Met QC Criteria

March 20, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T02/011/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

May be shared upon reasonable request to the PI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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