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

Sponsor
Mid and South Essex NHS Foundation Trust (Other)
Overall Status
Completed
CT.gov ID
NCT02643940
Collaborator
(none)
42
Enrollment
1
Location
32
Actual Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    42 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Oct 1, 2015
    Actual Primary Completion Date :
    May 31, 2018
    Actual Study Completion Date :
    May 31, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Coronary pressure changes [5 Minutes]

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

    Secondary Outcome Measures

    1. Population correlation [5 minutes]

      Correlation between coronary pressure---derived measurements in this population.

    2. Donor artery correlation [5 minutes]

      Correlation between collateral circulation function on coronary pressure - derived measurements in donor artery pre and post RCA CTO PCI.

    3. Cardiac MRI correlation [5 minutes]

      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)

    4. Effects of stenosis severity (QCA) [5 minutes]

      Effects of stenosis severity (QCA) in donor artery on coronary pressure-derived measurements

    5. Collateral circulation characteristics [5 minutes]

      Influence of collateral circulation characteristics on coronary pressure-derived measurements

    6. Coronary pressure and jeopardy scores correlation [5 minutes]

      Correlation between coronary pressure-derived measurements in the donor artery and myocardial jeopardy scores in the donor artery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    1. Presence of minor to intermediate coronary stenosis (1-70 %) in the contralateral donor artery

    2. 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)

    1. Haemodynamic instability at the time of intervention (heart rate <40 beats per minute, systolic blood pressure <90mmHg), balloon pump)

    2. Significant contraindication to adenosine administration (e.g. heart block, severe asthma)

    3. Contraindications to PCI

    4. Severe hepatic or lung disease (chronic pulmonary obstructive disease)

    5. Pregnancy

    6. ACS within 48 hours of procedure

    7. Severe valvular heart disease

    8. Severe cardiomyopathy / Infiltrative heart disease

    9. eGFR < 40

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Essex Cardiothoracic Centre Basildon Essex United Kingdom SS16 5NL

    Sponsors and Collaborators

    • Mid and South Essex NHS Foundation Trust

    Investigators

    • Principal Investigator: Thomas Keeble, MBBS MRCP, The Essex Cardiothoracic Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mid and South Essex NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT02643940
    Other Study ID Numbers:
    • B785
    First Posted:
    Dec 31, 2015
    Last Update Posted:
    Jan 11, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Mid and South Essex NHS Foundation Trust
    Percutaneous Coronary Intervention (PCI)
    Chronic Total Occlusion (CTO)
    Cardiac MRI
    Instantaneous wave-free ratio (iFR)
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Acute Coronary Syndrome

    Study Results

    No Results Posted as of Jan 11, 2022