NCT02643940

Brief Summary

This study will be recording pressure wire readings from both blocked and narrowed arteries, to better guide treatment options; medications, stents or potentially bypass surgery, for patients with Chronic Total Occlusion (CTO).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 31, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

2.7 years

First QC Date

December 22, 2015

Last Update Submit

December 20, 2021

Conditions

Acute Coronary SyndromeCoronary Artery Disease

Keywords

Percutaneous Coronary Intervention (PCI)Chronic Total Occlusion (CTO)Cardiac MRIInstantaneous wave-free ratio (iFR)

Outcome Measures

Primary Outcomes (1)

  • Coronary pressure changes

    Changes in coronary pressure - derived measurements (resting Pd/Pa, iFR and FFR) in donor artery pre and post RCA CTO PCI

    5 Minutes

Secondary Outcomes (6)

  • Population correlation

    5 minutes

  • Donor artery correlation

    5 minutes

  • Cardiac MRI correlation

    5 minutes

  • Effects of stenosis severity (QCA)

    5 minutes

  • Collateral circulation characteristics

    5 minutes

  • +1 more secondary outcomes

Eligibility Criteria

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

Patients scheduled for a PCI CTO

You may qualify if:

  • Age \>18 years of age
  • Stable angina / ischaemic symptoms
  • Evidence of viability and / or ischaemia in the chronic total occlusion (CTO) territory
  • Participant is willing and able to give informed consent for participation in the study
  • Presence of a chronic total occlusion (CTO) in RCA:
  • Duration of the occlusion \> 3 months;
  • Thrombolysis In Myocardial Infarction (TIMI) (50) coronary flow grade 0;
  • Spontaneously visible collaterals, Rentrop classification grade 1 or 2 or 3 from contralateral donor artery
  • Presence of minor to intermediate coronary stenosis (1-70 %) in the contralateral donor artery
  • Eligible for PCI to a chronic total occlusion (CTO)

You may not qualify if:

  • Previous CABG with patent grafts to the interrogated donor artery
  • Left main stenosis of \> 40 %
  • Presence of severe flow limiting stenosis in the contralateral donor artery (typically \> 70 % stenosis)
  • Haemodynamic instability at the time of intervention (heart rate \<40 beats per minute, systolic blood pressure \<90mmHg), balloon pump)
  • Significant contraindication to adenosine administration (e.g. heart block, severe asthma)
  • Contraindications to PCI
  • Severe hepatic or lung disease (chronic pulmonary obstructive disease)
  • Pregnancy
  • ACS within 48 hours of procedure
  • Severe valvular heart disease
  • Severe cardiomyopathy / Infiltrative heart disease
  • eGFR \< 40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Essex Cardiothoracic Centre

Basildon, Essex, SS16 5NL, United Kingdom

Location

Related Publications (2)

  • Karamasis GV, Kalogeropoulos AS, Mohdnazri SR, Al-Janabi F, Jones R, Jagathesan R, Aggarwal RK, Clesham GJ, Tang KH, Kelly PA, Davies JR, Werner GS, Keeble TR. Serial Fractional Flow Reserve Measurements Post Coronary Chronic Total Occlusion Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2018 Nov;11(11):e006941. doi: 10.1161/CIRCINTERVENTIONS.118.006941.

    PMID: 30571203RESULT

  • Mohdnazri SR, Karamasis GV, Al-Janabi F, Cook CM, Hampton-Till J, Zhang J, Al-Lamee R, Dungu JN, Gedela S, Tang KH, Kelly PA, Davies JE, Davies JR, Keeble TR. The impact of coronary chronic total occlusion percutaneous coronary intervention upon donor vessel fractional flow reserve and instantaneous wave-free ratio: Implications for physiology-guided PCI in patients with CTO. Catheter Cardiovasc Interv. 2018 Sep 1;92(3):E139-E148. doi: 10.1002/ccd.27587. Epub 2018 Mar 22.

    PMID: 29569332RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples (standard care no extra samples collected)

MeSH Terms

Conditions

Acute Coronary SyndromeCoronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Thomas Keeble, MBBS MRCP

    The Essex Cardiothoracic Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2015

First Posted

December 31, 2015

Study Start

October 1, 2015

Primary Completion

May 31, 2018

Study Completion

May 31, 2018

Last Updated

January 11, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)