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Chronic Total OcclusionNCT04226326

Investigating the Utility of Remote Index of Microvascular Resistance in Patients With Chronic Total Occlusion

A study testing Directly measure microvascular function using direct coronary flow measurements in people with Chronic Total Occlusion, run by University of Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is prospective cohort study in subjects with a planned percutaneous coronary intervention (PCI) of their chronic total occlusion (CTO). The study will enroll subjects who have been scheduled for a clinically-indicated cardiac catheterization, and will evaluate coronary microvascular function in all subjects… Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Chronic Total Occlusion
What is being tested?
Directly measure microvascular function using direct coronary flow measurements
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
15 Jan 2020to 17 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age ≥ 21 years
  • seen at University of Chicago Medical center with a planned PCI of a single CTO vessel
  • must have either stable angina or angina equivalent
  • must have a CTO with a clear donor vessel supplying most of the collaterals.

Who cannot join

  • subjects with a pacemaker or implantable cardioverter defibrillator
  • contraindication to cardiac MRI, adenosine, heparin, or nitroglycerin
  • cardiac transplantation
  • Estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73m2, given the risk of contrast-induced nephropathy (CIN) and nephrogenic systemic fibrosis (NSF) associated with iodinated and gadolinium-based contrast agents, respectively, in patients with significant renal dysfunction
  • Women who may potentially be pregnant will receive a pregnancy test and be excluded if pregnant
  • Vulnerable populations such as children, college students, prisoners, non-English speakers, and those with diminished decision-making capacity
  • Inability or refusal to consent for the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

Other trials in United States

About this study

This is prospective cohort study in subjects with a planned percutaneous coronary intervention (PCI) of their chronic total occlusion (CTO). The study will enroll subjects who have been scheduled for a clinically-indicated cardiac catheterization, and will evaluate coronary microvascular function in all subjects meeting inclusion criteria with a coronary flow wire. Evaluation of coronary microvascular function may be performed using indirect methods, however the rationale behind the present study is to directly measure microvascular function using direct coronary flow measurements, since the subjects in the study are to undergo a clinically-indicated cardiac catheterization. The overall purpose of the study is to define the presence and severity of coronary microvascular dysfunction subjects with CTO. The study is designed to enroll 50 subjects with CTO in the span of 3 years. There will be a 6-month assessment of the outcomes of death and cardiovascular death. As the study includes FDA approved tests, there will be no safety endpoint per se, however there will be a mechanism for monitoring adverse events as will be described in detail.

Being tested
Directly measure microvascular function using direct coronary flow measurements
Keywords
Microvascular Resistance, Percutaneous Coronary Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Directly measure microvascular function using direct coronary flow measurementsOther

    The study will enroll subjects who have been scheduled for a clinically-indicated cardiac catheterization, and will evaluate coronary microvascular function in all subjects meeting inclusion criteria with a coronary flow wire. Evaluation of coronary microvascular function may be performed using indirect methods, however the rationale behind the present study is to directly measure microvascular function using direct coronary flow measurements, since the subjects in the study are to undergo a clinically-indicated cardiac catheterization. The overall purpose of the study is to define the presence and severity of coronary microvascular dysfunction subjects with CTO.

Study groups in NCT04226326
Study groupRoleWhat they receive
Subjects with Chronic Total Occlusion (CTO)OtherAll subjects in this study have been scheduled for a clinically-indicated cardiac catheterization.
Receives: Other: Directly measure microvascular function using direct coronary flow measurements

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Baseline myocardial quality of the CTO-supplied vascular bed.

    Characterize the microvascular resistance of the donor vessel to 50 CTOs as it relates to vascular bed quality of the CTO-supplied territory. Scaled from 0-102, with 102 being worse than 0.

    1. Baseline myocardial quality

    Measured: Day of procedure

  2. IMR of opened CTO vessel

    Following CTO PCI, IMR of the opened vessel will be measured. Scale is linear and 1-100 units, higher numbers being worse outcome.

    1. Change in SAQ from baseline to 6 months

    Measured: 6 months

  3. Change in exercise time on Bruce protocol baseline

    Change in exercise time from baseline to 6 months post-PCI will be measured. Scale is linear and measured in seconds (can be a negative number), with higher numbers indicating a favorable outcome.

    Measured: 6 months

  4. Change in SAQ from baseline to 6 months

    Change in Seattle Angina Questionnaire (SAQ) from baseline to 6 months post-PCI will be measured. Scale is linear and 0-100 units, with higher numbers indicating a favorable outcome.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2020
  2. Study start15 Jan 2020
  3. Primary completion17 Jul 2023
  4. Study completion17 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04226326
Sponsor's protocol ID
IRB19-0654
Status last verified
Aug 2023
First submitted
18 Dec 2019
Last updated
24 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-360. doi: 10.1161/CIR.0000000000000350. Epub 2015 Dec 16. No abstract available.

    PubMed 26673558

  • Ramunddal T, Hoebers LP, Henriques JP, Dworeck C, Angeras O, Odenstedt J, Ioanes D, Olivecrona G, Harnek J, Jensen U, Aasa M, Jussila R, James S, Lagerqvist B, Matejka G, Albertsson P, Omerovic E. Chronic total occlusions in Sweden--a report from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). PLoS One. 2014 Aug 12;9(8):e103850. doi: 10.1371/journal.pone.0103850. eCollection 2014.

    PubMed 25117457

  • Fefer P, Knudtson ML, Cheema AN, Galbraith PD, Osherov AB, Yalonetsky S, Gannot S, Samuel M, Weisbrod M, Bierstone D, Sparkes JD, Wright GA, Strauss BH. Current perspectives on coronary chronic total occlusions: the Canadian Multicenter Chronic Total Occlusions Registry. J Am Coll Cardiol. 2012 Mar 13;59(11):991-7. doi: 10.1016/j.jacc.2011.12.007.

    PubMed 22402070

  • Claessen BE, van der Schaaf RJ, Verouden NJ, Stegenga NK, Engstrom AE, Sjauw KD, Kikkert WJ, Vis MM, Baan J Jr, Koch KT, de Winter RJ, Tijssen JG, Piek JJ, Henriques JP. Evaluation of the effect of a concurrent chronic total occlusion on long-term mortality and left ventricular function in patients after primary percutaneous coronary intervention. JACC Cardiovasc Interv. 2009 Nov;2(11):1128-34. doi: 10.1016/j.jcin.2009.08.024.

    PubMed 19926056

  • Puma JA, Sketch MH Jr, Tcheng JE, Gardner LH, Nelson CL, Phillips HR, Stack RS, Califf RM. The natural history of single-vessel chronic coronary occlusion: a 25-year experience. Am Heart J. 1997 Apr;133(4):393-9. doi: 10.1016/s0002-8703(97)70179-0.

    PubMed 9124159

  • Farooq V, Serruys PW, Garcia-Garcia HM, Zhang Y, Bourantas CV, Holmes DR, Mack M, Feldman T, Morice MC, Stahle E, James S, Colombo A, Diletti R, Papafaklis MI, de Vries T, Morel MA, van Es GA, Mohr FW, Dawkins KD, Kappetein AP, Sianos G, Boersma E. The negative impact of incomplete angiographic revascularization on clinical outcomes and its association with total occlusions: the SYNTAX (Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) trial. J Am Coll Cardiol. 2013 Jan 22;61(3):282-94. doi: 10.1016/j.jacc.2012.10.017. Epub 2012 Dec 19.

    PubMed 23265332

  • Christofferson RD, Lehmann KG, Martin GV, Every N, Caldwell JH, Kapadia SR. Effect of chronic total coronary occlusion on treatment strategy. Am J Cardiol. 2005 May 1;95(9):1088-91. doi: 10.1016/j.amjcard.2004.12.065.

    PubMed 15842978

  • Bagnall A, Spyridopoulos I. The evidence base for revascularisation of chronic total occlusions. Curr Cardiol Rev. 2014 May;10(2):88-98. doi: 10.2174/1573403x10666140331125659.

    PubMed 24694105

  • Brilakis ES, Banerjee S, Karmpaliotis D, Lombardi WL, Tsai TT, Shunk KA, Kennedy KF, Spertus JA, Holmes DR Jr, Grantham JA. Procedural outcomes of chronic total occlusion percutaneous coronary intervention: a report from the NCDR (National Cardiovascular Data Registry). JACC Cardiovasc Interv. 2015 Feb;8(2):245-253. doi: 10.1016/j.jcin.2014.08.014.

    PubMed 25700746

  • Henriques JP, Hoebers LP, Ramunddal T, Laanmets P, Eriksen E, Bax M, Ioanes D, Suttorp MJ, Strauss BH, Barbato E, Nijveldt R, van Rossum AC, Marques KM, Elias J, van Dongen IM, Claessen BE, Tijssen JG, van der Schaaf RJ; EXPLORE Trial Investigators. Percutaneous Intervention for Concurrent Chronic Total Occlusions in Patients With STEMI: The EXPLORE Trial. J Am Coll Cardiol. 2016 Oct 11;68(15):1622-1632. doi: 10.1016/j.jacc.2016.07.744.

    PubMed 27712774

Questions about this trial

What is this clinical trial studying?

A study testing Directly measure microvascular function using direct coronary flow measurements in people with Chronic Total Occlusion, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baseline myocardial quality of the CTO-supplied vascular bed. (time frame: Day of procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04226326, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.

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