NCT04073810

Brief Summary

Inflammation drives atherosclerotic plaque rupture triggering most acute coronary syndromes. Despite advances in diagnosis and management of atherosclerosis, patients with myocardial infarction (MI) remain at increased risk of recurrent events. The RIPPLE study aims to examine the relationship between residual coronary inflammation detected by 68Ga-DOTATATE PET in patients treated for MI to long-term plaque progression measured by CT coronary angiography (CTCA). The association between infarct-related myocardial 68Ga-DOTATATE PET and myocardial function and viability will also be assessed.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2019

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

4.2 years

First QC Date

August 27, 2019

Last Update Submit

July 18, 2024

Conditions

AtherosclerosisMyocardial InfarctionCoronary Artery DiseaseInflammation

Outcome Measures

Primary Outcomes (1)

  • 68Ga-DOTATATE PET vs. plaque progression

    Comparison of non-culprit coronary artery 68Ga-DOTATATE tissue-to-blood ratio at 12 weeks post-MI in patients with plaque progression (changes in low attenuation plaque volume and total atheroma volume) after 2 years measured by CTCA versus those without

    2 years

Secondary Outcomes (5)

  • 68Ga-DOTATATE PET vs. CTCA-defined plaque morphology

    2 years

  • 68Ga-DOTATATE PET vs. intravascular imaging

    Baseline

  • 68Ga-DOTATATE PET vs. hsCRP

    2 years

  • 68Ga-DOTATATE PET vs left ventricular myocardial function

    1 year

  • 68Ga-DOTATATE PET vs myocardial tissue characterization

    1 year

Study Arms (1)

Myocardial infarction

Patients with recent MI

Diagnostic Test: PET imagingDiagnostic Test: Coronary CT angiographyDiagnostic Test: Cardiac MRI

Interventions

PET imagingDIAGNOSTIC_TEST

Coronary 68Ga-DOTATATE PET-MRI or PET-CT at baseline and 3 months

Myocardial infarction
Coronary CT angiographyDIAGNOSTIC_TEST

CTCA at baseline and 2 years

Myocardial infarction
Cardiac MRIDIAGNOSTIC_TEST

Cardiac MRI at 1 year

Myocardial infarction

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with recent myocardial infarction and medically managed non-culprit coronary artery disease

You may qualify if:

  • Male or female participants \>18 years old
  • Able to give written, informed consent and to lie flat
  • First-presentation of myocardial infarction within \~2 weeks
  • At least mild non-culprit coronary artery disease on angiography, managed medically

You may not qualify if:

  • Women of child bearing potential not using adequate contraception
  • Contrast allergy or contrast-nephropathy
  • Uncontrolled atrial fibrillation
  • Chronic kidney disease (eGFR \<30 mL/min/1.73 m2)
  • Any medical condition, in the opinion of the investigator, that prevents the participant from lying flat during scanning, or from participating in the study
  • Uncontrolled chronic inflammatory disorder
  • History of recent malignancy deemed relevant to the study by the investigator
  • Current use of systemic corticosteroids
  • Previous coronary artery bypass grafting surgery (CABG) or percutaneous coronary intervention (PCI) before the index event
  • Contraindication to coronary angiography
  • Requires CABG or staged non-culprit artery PCI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cambridge

Cambridge, United Kingdom

Location

Related Publications (4)

  • Tarkin JM, Joshi FR, Evans NR, Chowdhury MM, Figg NL, Shah AV, Starks LT, Martin-Garrido A, Manavaki R, Yu E, Kuc RE, Grassi L, Kreuzhuber R, Kostadima MA, Frontini M, Kirkpatrick PJ, Coughlin PA, Gopalan D, Fryer TD, Buscombe JR, Groves AM, Ouwehand WH, Bennett MR, Warburton EA, Davenport AP, Rudd JH. Detection of Atherosclerotic Inflammation by 68Ga-DOTATATE PET Compared to [18F]FDG PET Imaging. J Am Coll Cardiol. 2017 Apr 11;69(14):1774-1791. doi: 10.1016/j.jacc.2017.01.060.

    PMID: 28385306BACKGROUND

  • Pedersen SF, Sandholt BV, Keller SH, Hansen AE, Clemmensen AE, Sillesen H, Hojgaard L, Ripa RS, Kjaer A. 64Cu-DOTATATE PET/MRI for Detection of Activated Macrophages in Carotid Atherosclerotic Plaques: Studies in Patients Undergoing Endarterectomy. Arterioscler Thromb Vasc Biol. 2015 Jul;35(7):1696-703. doi: 10.1161/ATVBAHA.114.305067. Epub 2015 May 14.

    PMID: 25977567BACKGROUND

  • Rominger A, Saam T, Vogl E, Ubleis C, la Fougere C, Forster S, Haug A, Cumming P, Reiser MF, Nikolaou K, Bartenstein P, Hacker M. In vivo imaging of macrophage activity in the coronary arteries using 68Ga-DOTATATE PET/CT: correlation with coronary calcium burden and risk factors. J Nucl Med. 2010 Feb;51(2):193-7. doi: 10.2967/jnumed.109.070672. Epub 2010 Jan 15.

    PMID: 20080898BACKGROUND

  • Corovic A, Wall C, Nus M, Gopalan D, Huang Y, Imaz M, Zulcinski M, Peverelli M, Uryga A, Lambert J, Bressan D, Maughan RT, Pericleous C, Dubash S, Jordan N, Jayne DR, Hoole SP, Calvert PA, Dean AF, Rassl D, Barwick T, Iles M, Frontini M, Hannon G, Manavaki R, Fryer TD, Aloj L, Graves MJ, Gilbert FJ, Dweck MR, Newby DE, Fayad ZA, Reynolds G, Morgan AW, Aboagye EO, Davenport AP, Jorgensen HF, Mallat Z, Bennett MR, Peters JE, Rudd JHF, Mason JC, Tarkin JM. Somatostatin Receptor PET/MR Imaging of Inflammation in Patients With Large Vessel Vasculitis and Atherosclerosis. J Am Coll Cardiol. 2023 Jan 31;81(4):336-354. doi: 10.1016/j.jacc.2022.10.034.

    PMID: 36697134DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimens

MeSH Terms

Conditions

AtherosclerosisMyocardial InfarctionCoronary Artery DiseaseInflammation

Interventions

Positron-Emission Tomography

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesMyocardial IschemiaHeart DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCoronary Disease

Intervention Hierarchy (Ancestors)

Tomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisImage EnhancementPhotographyRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • Jason M Tarkin, MBBS PhD

    University of Cambridge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Wellcome Clinical Research Career Development Fellow & Clinical Lecturer

Study Record Dates

First Submitted

August 27, 2019

First Posted

August 29, 2019

Study Start

October 1, 2020

Primary Completion

December 1, 2024

Study Completion

April 1, 2025

Last Updated

July 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)