NCT04892537

Brief Summary

ORBITA-COSMIC is a randomised, double-blinded, placebo controlled trial of the coronary sinus reducer (CSR). The investigators will compare the effects of CSR versus placebo on myocardial perfusion on MRI, exercise time and symptoms in 50 participants with refractory angina and ischaemia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

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

April 30, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 19, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

May 21, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

2.6 years

First QC Date

April 30, 2021

Last Update Submit

October 26, 2023

Conditions

Refractory Angina

Outcome Measures

Primary Outcomes (1)

  • Myocardial Blood Flow

    On cardiac MRI, with adenosine stress, millilitres/gram/minute

    6 months

Secondary Outcomes (28)

  • Myocardial perfusion reserve (MPR) in ischaemic segments, non ischaemic segments and global MPR

    6 months

  • Rest myocardial blood flow (MBF) in ischaemic segments, non ischaemic segments and global rest MBF

    6 months

  • Stress myocardial blood flow (MBF) in ischaemic segments, non ischaemic segments and global stress MBF

    6 months

  • MPR in ischaemic segments with inferior and inferoseptal segments excluded

    6 months

  • MBF in ischaemic segments with inferior and inferoseptal segments excluded

    6 months

  • +23 more secondary outcomes

Study Arms (2)

CSR

ACTIVE COMPARATOR

Coronary Sinus Reducer implantation

Device: Coronary Sinus Reducer

Placebo

PLACEBO COMPARATOR

Placebo procedure

Procedure: Placebo Procedure

Interventions

Coronary Sinus ReducerDEVICE

Coronary Sinus Reducer implantation according to standard clinical protocols

Also known as: CSR
CSR
Placebo ProcedurePROCEDURE

A placebo procedure involving venous sheath implantation in the right internal jugular vein without proceeding to CSR implantation

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable coronary artery disease (CAD) not eligible for percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG)
  • Evidence of ischaemia on stress perfusion CMR
  • Angina - Canadian Cardiovascular Society Class II-VI on maximal medical therapy

You may not qualify if:

  • Age\<18 years
  • Pregnancy
  • Inability to consent
  • Recent acute coronary syndrome (3 months)
  • Recent revascularisation (6 months)
  • Permanent pacemaker or defibrillator leads in the right heart
  • Severe left ventricular impairment (\<25%)
  • Indication for cardiac resynchronisation therapy (CRT)
  • Right atrial pressure ≥15mmHg
  • Life expectancy \<1 year
  • Severe renal impairment (eGFR\<15)
  • Contraindication to CMR
  • Contraindication to adenosine
  • Ischaemia isolated to inferior wall
  • Ongoing participation in a separate interventional study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Basildon and Thurrock Hospitals NHS Foundation Trust

Basildon, United Kingdom

NOT YET RECRUITING

Royal Bournemouth Hospital

Bournemouth, United Kingdom

NOT YET RECRUITING

Imperial College Healthcare NHS Trust

London, United Kingdom

RECRUITING

St George's Hospital

London, United Kingdom

NOT YET RECRUITING

The Royal Brompton Hospital

London, United Kingdom

NOT YET RECRUITING

Related Publications (2)

  • Foley MJ, Rajkumar CA, Ahmed-Jushuf F, Simader FA, Chotai S, Pathimagaraj RH, Mohsin M, Salih A, Wang D, Dixit P, Davies JR, Keeble TR, Cosgrove C, Spratt JC, O'Kane PD, De Silva R, Hill JM, Nijjer SS, Sen S, Petraco R, Mikhail GW, Khamis R, Kotecha T, Harrell FE, Kellman P, Francis DP, Howard JP, Cole GD, Shun-Shin MJ, Al-Lamee RK. Coronary sinus reducer for the treatment of refractory angina (ORBITA-COSMIC): a randomised, placebo-controlled trial. Lancet. 2024 Apr 20;403(10436):1543-1553. doi: 10.1016/S0140-6736(24)00256-3. Epub 2024 Apr 8.

    PMID: 38604209DERIVED

  • Foley MJ, Rajkumar CA, Ahmed-Jushuf F, Simader F, Pathimagaraj RH, Nijjer S, Sen S, Petraco R, Clesham G, Johnson T, Harrell FE Jr, Kellman P, Francis D, Shun-Shin M, Howard J, Cole GD, Al-Lamee R. A double-blind, randomised, placebo-controlled trial of the coronary sinus Reducer in refractory angina: design and rationale of the ORBITA-COSMIC trial. EuroIntervention. 2024 Feb 5;20(3):e216-e223. doi: 10.4244/EIJ-D-23-00567.

    PMID: 38214677DERIVED

MeSH Terms

Conditions

Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Rasha Al-Lamee, PhD MRCP

CONTACT

020 7594 5735r.al-lamee13@imperial.ac.uk

Michael Foley, MBBS MRCP

CONTACT

020 7594 5735m.foley@imperial.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2021

First Posted

May 19, 2021

Study Start

May 21, 2021

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

October 30, 2023

Record last verified: 2023-10

Locations

GB(5)