NCT06039059

Brief Summary

This study enrolled patients who used to received PCI therapy with nonintervened coronary lesions. Baseline characteristics and laboratory testing were collected to find out the risk factor difference between ISR and nonintervened coronary lesions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
510

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 15, 2023

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

3 years

First QC Date

September 7, 2023

Last Update Submit

September 13, 2023

Conditions

Coronary Artery DiseaseMulti Vessel Coronary Artery Disease

Keywords

ISR, nonintervened coronary lesions, risk factor

Outcome Measures

Primary Outcomes (1)

  • LDL-C, mmol/L

    Low-density cholesterol (LDL-C) is the cholesterol in low-density lipoprotein (LDL), which reflects how much LDL is present.

    Blood samples were collected after a 12-hour fast before CAG.

Secondary Outcomes (3)

  • HbA1c, %

    Blood samples were collected after a 12-hour fast before CAG.

  • ALT, U/L

    Blood samples were collected after a 12-hour fast before CAG.

  • Scr, mmol/L

    Blood samples were collected after a 12-hour fast before CAG.

Study Arms (1)

Receiving PCI with nonintervened coronary lesion

Patients who received PCI with nonintervened coronary lesion.

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with multivessel lesions that had treated part of the vessels.

You may qualify if:

  • (1) PCI therapy with drug-coated stents was performed in the past, and nonintervened coronary lesion remained except in the target vessel.
  • (2) CAG was performed again due to re-examination, recurrent angina symptoms, positive treadmill exercise test or coronary CTA showing moderate to severe vessel diameter stenosis.
  • (3) Long-term regular oral administration of statins and lipid monitoring were conducted after PCI.

You may not qualify if:

  • Patients with a history of CABG, renal replacement therapy, autoimmune disease, and malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital

Shanghai, 200127, China

Location

Related Publications (11)

  • Tsao CW, Aday AW, Almarzooq ZI, Alonso A, Beaton AZ, Bittencourt MS, Boehme AK, Buxton AE, Carson AP, Commodore-Mensah Y, Elkind MSV, Evenson KR, Eze-Nliam C, Ferguson JF, Generoso G, Ho JE, Kalani R, Khan SS, Kissela BM, Knutson KL, Levine DA, Lewis TT, Liu J, Loop MS, Ma J, Mussolino ME, Navaneethan SD, Perak AM, Poudel R, Rezk-Hanna M, Roth GA, Schroeder EB, Shah SH, Thacker EL, VanWagner LB, Virani SS, Voecks JH, Wang NY, Yaffe K, Martin SS. Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association. Circulation. 2022 Feb 22;145(8):e153-e639. doi: 10.1161/CIR.0000000000001052. Epub 2022 Jan 26.

    PMID: 35078371BACKGROUND

  • Patil CV, Nikolsky E, Boulos M, Grenadier E, Beyar R. Multivessel coronary artery disease: current revascularization strategies. Eur Heart J. 2001 Jul;22(14):1183-97. doi: 10.1053/euhj.2000.2497. No abstract available.

    PMID: 11440491BACKGROUND

  • Rigattieri S, Biondi-Zoccai G, Silvestri P, Di Russo C, Musto C, Ferraiuolo G, Loschiavo P. Management of multivessel coronary disease after ST elevation myocardial infarction treated by primary angioplasty. J Interv Cardiol. 2008 Feb;21(1):1-7. doi: 10.1111/j.1540-8183.2007.00317.x. Epub 2007 Dec 12.

    PMID: 18086133BACKGROUND

  • Nicolais C, Lakhter V, Virk HUH, Sardar P, Bavishi C, O'Murchu B, Chatterjee S. Therapeutic Options for In-Stent Restenosis. Curr Cardiol Rep. 2018 Feb 12;20(2):7. doi: 10.1007/s11886-018-0952-4.

    PMID: 29435779BACKGROUND

  • Erdogan E, Bajaj R, Lansky A, Mathur A, Baumbach A, Bourantas CV. Intravascular Imaging for Guiding In-Stent Restenosis and Stent Thrombosis Therapy. J Am Heart Assoc. 2022 Nov 15;11(22):e026492. doi: 10.1161/JAHA.122.026492. Epub 2022 Nov 3.

    PMID: 36326067BACKGROUND

  • Schupke S, Tiroch K. Acute Coronary Syndromes and the Nontarget Lesion. J Am Coll Cardiol. 2020 Mar 17;75(10):1107-1110. doi: 10.1016/j.jacc.2020.01.027. No abstract available.

    PMID: 32164883BACKGROUND

  • Fukushima T, Yonetsu T, Aoyama N, Tashiro A, Niida T, Shiheido-Watanabe Y, Maejima Y, Isobe M, Iwata T, Sasano T. Effect of Periodontal Disease on Long-Term Outcomes After Percutaneous Coronary Intervention for De Novo Coronary Lesions in Non-Smokers. Circ J. 2022 Apr 25;86(5):811-818. doi: 10.1253/circj.CJ-21-0720. Epub 2021 Nov 18.

    PMID: 34789614BACKGROUND

  • Kimura T, Morimoto T, Nakagawa Y, Kawai K, Miyazaki S, Muramatsu T, Shiode N, Namura M, Sone T, Oshima S, Nishikawa H, Hiasa Y, Hayashi Y, Nobuyoshi M, Mitudo K; j-Cypher Registry Investigators. Very late stent thrombosis and late target lesion revascularization after sirolimus-eluting stent implantation: five-year outcome of the j-Cypher Registry. Circulation. 2012 Jan 31;125(4):584-91. doi: 10.1161/CIRCULATIONAHA.111.046599. Epub 2011 Dec 27.

    PMID: 22203694BACKGROUND

  • Glaser R, Selzer F, Faxon DP, Laskey WK, Cohen HA, Slater J, Detre KM, Wilensky RL. Clinical progression of incidental, asymptomatic lesions discovered during culprit vessel coronary intervention. Circulation. 2005 Jan 18;111(2):143-9. doi: 10.1161/01.CIR.0000150335.01285.12. Epub 2004 Dec 27.

    PMID: 15623544BACKGROUND

  • Park MW, Seung KB, Kim PJ, Park HJ, Yoon SG, Baek JY, Koh YS, Jung HO, Chang K, Kim HY, Baek SH. Long-term percutaneous coronary intervention rates and associated independent predictors for progression of nonintervened nonculprit coronary lesions. Am J Cardiol. 2009 Sep 1;104(5):648-52. doi: 10.1016/j.amjcard.2009.04.052.

    PMID: 19699339BACKGROUND

  • Kaneko H, Yajima J, Oikawa Y, Tanaka S, Fukamachi D, Suzuki S, Sagara K, Otsuka T, Matsuno S, Kano H, Uejima T, Koike A, Nagashima K, Kirigaya H, Sawada H, Aizawa T, Yamashita T. Long-term incidence and prognostic factors of the progression of new coronary lesions in Japanese coronary artery disease patients after percutaneous coronary intervention. Heart Vessels. 2014 Jul;29(4):437-42. doi: 10.1007/s00380-013-0382-6. Epub 2013 Jun 27.

    PMID: 23807613BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2023

First Posted

September 15, 2023

Study Start

January 1, 2020

Primary Completion

December 31, 2022

Study Completion

March 31, 2023

Last Updated

September 15, 2023

Record last verified: 2023-09

Locations

CN(1)