AzTrials
AzTrials

Coronary Artery DiseaseNCT06039059

Influence of Risk Factors on ISR and Nonintervened Lesions

An observational study of Coronary Artery Disease and Multi Vessel Coronary Artery Disease, run by RenJi Hospital at 1 site in China.

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 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. Read more about this study

Who is it for?
Any age
How many people
510 participants
Where
1 siteChina
Study dates
1 Jan 2020to 31 Mar 2023
Phase
Observational
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 Any age
  • All sexes
  • Child, Adult, Older adult

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

Who may be able to join

  • (1) PCI therapy with drug-coated stents was performed in the past, and nonintervened coronary lesion remained except in the target vessel.
  • 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.
  • Long-term regular oral administration of statins and lipid monitoring were conducted after PCI.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Renji Hospital

    Shanghai, 200127

Other trials in China

About this study

Official title: Influence of Risk Factors Such as Serum Cholesterol Level on ISR and Nonintervened Coronary Lesions

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.

Keywords
ISR, nonintervened coronary lesions, risk factor
Medical subject headings
Coronary Artery Disease

What participants receive

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

Study groups in NCT06039059
Study groupRoleWhat they receive
Receiving PCI with nonintervened coronary lesionPatients who received PCI with nonintervened coronary lesion.

What is being measured

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

  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.

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

Secondary outcomes (3)

  1. HbA1c, %

    Hemoglobin a1c (HbA1c) is the combination of hemoglobin and blood sugar. Its concentration in the blood is stable and is not affected by short-term blood sugar concentrations. Hemoglobin A1C has obvious clinical value in the diagnosis of diabetes.

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

  2. ALT, U/L

    Alanine aminotransferase (ALT) mainly exists in the plasma of liver cells, and the intracellular concentration is 1000-3000 times higher than that in serum. As long as 1% of liver cells are destroyed, it can double the serum enzyme. Therefore, alanine transaminase is recommended by the World Health Organization as the most sensitive detection index of liver function damage.

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

  3. Scr, mmol/L

    Serum creatinine (Scr) is a compound produced in muscles during the production of energy. Healthy kidneys filter creatinine from the blood. Creatinine is excreted in the urine as a metabolite and is a common measure of the kidney's filtration function. Creatinine this indicator belongs to the blood biochemical test, the higher the creatinine level, usually indicates the worse the kidney function.

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

Timeline

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

  1. First posted15 Sep 2023
  2. Study start1 Jan 2020
  3. Primary completion31 Dec 2022
  4. Study completion31 Mar 2023

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
510 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06039059
Sponsor's protocol ID
Rf on ISR and nonintervented
Status last verified
Sep 2023
First submitted
7 Sep 2023
Last updated
15 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 35078371

  • 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.

    PubMed 11440491

  • 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.

    PubMed 18086133

  • 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.

    PubMed 29435779

  • 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.

    PubMed 36326067

  • 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.

    PubMed 32164883

  • 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.

    PubMed 34789614

  • 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.

    PubMed 22203694

  • 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.

    PubMed 15623544

  • 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.

    PubMed 19699339

  • 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.

    PubMed 23807613

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Multi Vessel Coronary Artery Disease, run by RenJi Hospital at 1 site in China.

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 3 inclusion and 1 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 15 Sep 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 China. 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?

LDL-C, mmol/L (time frame: Blood samples were collected after a 12-hour fast before CAG.). 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 NCT06039059, which also lists 11 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 15 Sep 2023.

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