The Physiological Impact of CTO PCI on Coronary Pressure Measurements and Correlation in Donor Vessel (IMPACT-CTO)

The Physiological IMPACT of Coronary Chronic Total Occlusion (CTO) Percutaneous Coronary Intervention (PCI) on Coronary Pressure --Derived Measurements, Its Correlation in the Donor Vessel and the Influence of Collateral Circulation

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).

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Acute Coronary Syndrome

Detailed Description

The patients in this study are planned to have a Percutaneous Coronary Intervention (PCI) with recanalization of Chronic Total Occlusion (CTO) on clinical grounds alone.

This study will be recording pressure wire readings from both blocked and narrowed arteries, to better guide treatment option. To date there is no data available on instantaneous wave free ratio (iFR) measurement (a pressure derived assessment of flow limitation) in patients with blocked arteries.

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• United Kingdom
  • Essex
    • Basildon, Essex, United Kingdom, SS16 5NL
      • The Essex Cardiothoracic Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients scheduled for a PCI CTO

Description

Inclusion Criteria:

1. Age >18 years of age
2. Stable angina / ischaemic symptoms
3. Evidence of viability and / or ischaemia in the chronic total occlusion (CTO) territory
4. Participant is willing and able to give informed consent for participation in the study

5. 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
6. Presence of minor to intermediate coronary stenosis (1-70 %) in the contralateral donor artery
7. Eligible for PCI to a chronic total occlusion (CTO)

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Population correlation	Correlation between coronary pressure---derived measurements in this population.	5 minutes
Donor artery correlation	Correlation between collateral circulation function on coronary pressure - derived measurements in donor artery pre and post RCA CTO PCI.	5 minutes
Cardiac MRI correlation	Correlation between baseline coronary pressure - derived measurements in donor artery pre RCA CTO PCI, collateral circulation indices and baseline non-invasive functional assessment /Cardiac MRI (CMR)	5 minutes
Effects of stenosis severity (QCA)	Effects of stenosis severity (QCA) in donor artery on coronary pressure-derived measurements	5 minutes
Collateral circulation characteristics	Influence of collateral circulation characteristics on coronary pressure-derived measurements	5 minutes
Coronary pressure and jeopardy scores correlation	Correlation between coronary pressure-derived measurements in the donor artery and myocardial jeopardy scores in the donor artery	5 minutes

Collaborators and Investigators

• Sponsor: Mid and South Essex NHS Foundation Trust
• Investigators: Principal Investigator: Thomas Keeble, MBBS MRCP, The Essex Cardiothoracic Centre

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: December 22, 2015
• First Submitted That Met QC Criteria: December 30, 2015
• First Posted (Estimate): December 31, 2015

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Cardiac MRI; Percutaneous Coronary Intervention (PCI); Chronic Total Occlusion (CTO); Instantaneous wave-free ratio (iFR)
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Acute Coronary Syndrome
• Other Study ID Numbers: B785

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO