Clinical trial NCT02643940: The Physiological Impact of CTO PCI on Coronary Pressure Measurements and Correlation in Donor Vessel
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Coronary Artery Disease
Keywords: Percutaneous Coronary Intervention (PCI)
Chronic Total Occlusion (CTO)
Cardiac MRI
Instantaneous wave-free ratio (iFR)
Lead sponsor: Mid and South Essex NHS Foundation Trust
Sponsor class: OTHER
First posted: 2015-12-31
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for a PCI CTO

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Coronary pressure changes
timeFrame: 5 Minutes
Secondary outcomes:
measure: Population correlation
timeFrame: 5 minutes
measure: Donor artery correlation
timeFrame: 5 minutes
measure: Cardiac MRI correlation
timeFrame: 5 minutes
measure: Effects of stenosis severity (QCA)
timeFrame: 5 minutes
measure: Collateral circulation characteristics
timeFrame: 5 minutes
measure: Coronary pressure and jeopardy scores correlation
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Basildon
country: United Kingdom
facility: The Essex Cardiothoracic Centre
state: Essex
Study officials:
affiliation: The Essex Cardiothoracic Centre
name: Thomas Keeble, MBBS MRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.