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Active, not recruitingNCT04073810RIPPLEUpdated Jul 19, 2024

Residual Inflammation and Plaque Progression Long-term Evaluation

An observational study in Atherosclerosis, Myocardial Infarction and Coronary Artery Disease, sponsored by University of Cambridge. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-07-19.

Sponsored by University of Cambridge · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the detailed description

While vascular inflammation can be detected using 18F-FDG PET, this method lacks inflammatory cell specificity and is unreliable for coronary imaging because of high background signals from the myocardium. Upregulation of somatostatin receptor subtype-2 (SST2) occurs in activated macrophages, offering a novel inflammation imaging target. 68Ga-DOTATATE, an SST2 PET tracer with low myocardial binding, shows promise for imaging coronary inflammation. Having previously demonstrated increased 68Ga-DOTATATE signals in coronary atherosclerotic lesions post-MI, we now aim to study the natural history of residual arterial inflammation in non-culprit arteries and better understand how 68Ga-DOTATATE signals relate to plaque morphology, progression and rupture. Residual infarct-related myocardial inflammation and its association with ischemic myocardial remodelling will also be examined.

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Conditions studied

  • Atherosclerosis
  • Myocardial Infarction
  • Coronary Artery Disease
  • Inflammation
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In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 40 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

University of Cambridge is the lead sponsor of 112 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Myocardial infarction

    Patients with recent MI

    Diagnostic Test: PET imaging · Diagnostic Test: Coronary CT angiography · Diagnostic Test: Cardiac MRI

Interventions

  • Diagnostic testPET imaging

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

  • Diagnostic testCoronary CT angiography

    CTCA at baseline and 2 years

  • Diagnostic testCardiac MRI

    Cardiac MRI at 1 year

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What researchers measure

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

    Time frame: 2 years

Secondary outcomes

  1. 68Ga-DOTATATE PET vs. CTCA-defined plaque morphology

    Comparison of coronary 68Ga-DOTATATE imaging to changes in plaque morphology measured by CTCA

    Time frame: 2 years

  2. 68Ga-DOTATATE PET vs. intravascular imaging

    Comparison of 68Ga-DOTATATE imaging to plaque morphology defined by high-resolution intravascular imaging performed during invasive coronary angiography

    Time frame: Baseline

  3. 68Ga-DOTATATE PET vs. hsCRP

    Comparison of 68Ga-DOTATATE PET to high-sensitivity C-reactive protein

    Time frame: 2 years

  4. 68Ga-DOTATATE PET vs left ventricular myocardial function

    Comparison of myocardial 68Ga-DOTATATE PET to left ventricular size and function

    Time frame: 1 year

  5. 68Ga-DOTATATE PET vs myocardial tissue characterization

    Comparison of myocardial 68Ga-DOTATATE PET to myocardial scarring and oedema

    Time frame: 1 year

07

Study locations

1 site
  • University of Cambridge
    Cambridge, United Kingdom
08

References and documents

Publications

  • 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. PubMed 28385306 ↗
  • 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. PubMed 25977567 ↗
  • 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. PubMed 20080898 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04073810
Lead sponsor
University of Cambridge
Collaborators
Cambridge University Hospitals NHS Foundation Trust, Wellcome Trust
Responsible party
Jason Tarkin (Wellcome Clinical Research Career Development Fellow & Clinical Lecturer, University of Cambridge) — Principal investigator
First posted
Aug 29, 2019
Start date
Oct 1, 2020
Primary completion
Dec 1, 2024 (estimated)
Completion
Apr 1, 2025 (estimated)
Last update
Jul 19, 2024

Study contacts

Jason M Tarkin, MBBS PhD
principal investigator · University of Cambridge

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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