Viable Myocardium Detected by Hybrid PET/MR and SPECT for the Prediction of the Efficacy of PCI in Patients With CTO.

NCT06113835 | Unknown DMC

• 1 other identifier: 022
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

CTO intervention is controversial, and viable myocardium is critical to the improvement of cardiac function and prognosis of patients. However, it remains uncertain whether viable myocardium detected by Hybrid PET/MR and SPECT Imaging improves the PCI efficacy in Patients With CTO. In this investigator-initiated, prospective, single-center, observational trial, patients meeting the inclusion/exclusion criteria would be assigned to the successful group or the unsuccessful group based on the success of PCI, both undergoing pre-operative and 6-month follow-up Hybrid PET/MR and SPECT imaging. The improvement of left ventricular (LV) recovery after 6 months will be observed.

Conditions

Chronic Total Occlusion of Coronary Artery

Keywords

Chronic Total Occlusion of Coronary Artery; viable myocardium; Hybrid PET/MR and SPECT Imaging; Percutaneous coronary intervention

Outcome Measures

Primary Outcomes (2)

• left ventricular ejection fraction increased by ≥5%

  PET/MR postoperative follow-up

  6±1 month

• Segmental ventricular wall motion score decreased by ≥1

  PET/MR postoperative follow-up

  6±1 month

Study Arms (2)

successful group

CTO PCI Technical success ,deployment of a balloon or stent with final antegrade TIMI flow grade 2 or 3, residual stenosis \<30% , and no significant side branch occlusion.

Procedure: CTO PCI

unsuccessful group

CTO PCI Technical unsuccess

Procedure: CTO PCI

Interventions

CTO PCI PROCEDURE

percutaneous coronary intervention

successful group; unsuccessful group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with symptomatic coronary artery disease (CAD) (angina or angina equivalent) in the presence of a CTO of a relevant coronary artery

You may qualify if:

• Age ≧ 18 years, \< 75 years;
• complete occlusion of the coronary artery, confirmed by coronary angiography with TIMI flow grade 0, and occlusion for ≥3 months;
• presence of angina or angina-equivalent symptoms ; undergo coronary intervention;

You may not qualify if:

• life expectancy \< 1 year due to non-cardiac disease;
• contraindications to SPECT/PET/MRI: pregnancy, contrast allergy, claustrophobia, history of pacemaker and ICD implantation, other ferromagnetic materials in the body;
• acute coronary syndrome within the last 3 months;
• severe valvular heart disease;
• haemodynamic instability;
• hepatic or renal insufficiency, with alanine aminotransferase (ALT) \> 3 times the upper limit of normal or glomerular filtration rate ≤ 30 mL/min;
• two or more CTO lesions;
• previous myocardial infarction.
• Others who, in the opinion o f the investigator, should not be enrolled;

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Related Publications (10)

• Azzalini L, Jolicoeur EM, Pighi M, Millan X, Picard F, Tadros VX, Fortier A, L'Allier PL, Ly HQ. Epidemiology, Management Strategies, and Outcomes of Patients With Chronic Total Coronary Occlusion. Am J Cardiol. 2016 Oct 15;118(8):1128-1135. doi: 10.1016/j.amjcard.2016.07.023. Epub 2016 Jul 28.

  PMID: 27561190 BACKGROUND

• Hamzaraj K, Kammerlander A, Gyongyosi M, Frey B, Distelmaier K, Graf S. Patient Selection and Clinical Indication for Chronic Total Occlusion Revascularization-A Workflow Focusing on Non-Invasive Cardiac Imaging. Life (Basel). 2022 Dec 20;13(1):4. doi: 10.3390/life13010004.

  PMID: 36675954 BACKGROUND

• Mehran R, Claessen BE, Godino C, Dangas GD, Obunai K, Kanwal S, Carlino M, Henriques JP, Di Mario C, Kim YH, Park SJ, Stone GW, Leon MB, Moses JW, Colombo A; Multinational Chronic Total Occlusion Registry. Long-term outcome of percutaneous coronary intervention for chronic total occlusions. JACC Cardiovasc Interv. 2011 Sep;4(9):952-61. doi: 10.1016/j.jcin.2011.03.021.

  PMID: 21939934 BACKGROUND

• 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.

  PMID: 27712774 BACKGROUND

• Ryan M, Morgan H, Chiribiri A, Nagel E, Cleland J, Perera D. Myocardial viability testing: all STICHed up, or about to be REVIVED? Eur Heart J. 2022 Jan 13;43(2):118-126. doi: 10.1093/eurheartj/ehab729.

  PMID: 34791132 BACKGROUND

• Ling LF, Marwick TH, Flores DR, Jaber WA, Brunken RC, Cerqueira MD, Hachamovitch R. Identification of therapeutic benefit from revascularization in patients with left ventricular systolic dysfunction: inducible ischemia versus hibernating myocardium. Circ Cardiovasc Imaging. 2013 May 1;6(3):363-72. doi: 10.1161/CIRCIMAGING.112.000138. Epub 2013 Apr 17.

  PMID: 23595888 BACKGROUND

• Allman KC. Noninvasive assessment myocardial viability: current status and future directions. J Nucl Cardiol. 2013 Aug;20(4):618-37; quiz 638-9. doi: 10.1007/s12350-013-9737-8. Epub 2013 Jun 15.

  PMID: 23771636 BACKGROUND

• Dilsizian V, Bacharach SL, Beanlands RS, Bergmann SR, Delbeke D, Dorbala S, Gropler RJ, Knuuti J, Schelbert HR, Travin MI. ASNC imaging guidelines/SNMMI procedure standard for positron emission tomography (PET) nuclear cardiology procedures. J Nucl Cardiol. 2016 Oct;23(5):1187-1226. doi: 10.1007/s12350-016-0522-3. Epub 2016 Jul 8. No abstract available.

  PMID: 27392702 BACKGROUND

• Kwong RY, Chan AK, Brown KA, Chan CW, Reynolds HG, Tsang S, Davis RB. Impact of unrecognized myocardial scar detected by cardiac magnetic resonance imaging on event-free survival in patients presenting with signs or symptoms of coronary artery disease. Circulation. 2006 Jun 13;113(23):2733-43. doi: 10.1161/CIRCULATIONAHA.105.570648. Epub 2006 Jun 5.

  PMID: 16754804 BACKGROUND

• Vitadello T, Kunze KP, Nekolla SG, Langwieser N, Bradaric C, Weis F, Cassese S, Fusaro M, Hapfelmeier A, Lewalter T, Schwaiger M, Kastrati A, Laugwitz KL, Rischpler C, Ibrahim T. Hybrid PET/MR imaging for the prediction of left ventricular recovery after percutaneous revascularisation of coronary chronic total occlusions. Eur J Nucl Med Mol Imaging. 2020 Dec;47(13):3074-3083. doi: 10.1007/s00259-020-04877-w. Epub 2020 May 30.

  PMID: 32472438 BACKGROUND

Study Officials

• Chunjian Li, Dr,PhD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunjian Li, Dr,PhD

CONTACT

+86-13701465229; drcjli@hotmail.com

Kun Liu, MD

CONTACT

+86-18961322023; liukun2023@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiology

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 2, 2023
• Study Start: February 22, 2023
• Primary Completion: October 30, 2024
• Study Completion: March 30, 2025
• Last Updated: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)