SCS for Vasospastic Angina Vasospastic Angina Pectoris - a Prospective Study

NCT06176391 | Unknown FDA Device

• 1 other identifier: NL79947.018.21
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

According to the 2020 Dutch guideline on chest pain (AP) without obstructive coronary artery disease, 70% of female and 30% of male patients undergoing a coronary angiogram (CAG), have no obstructive coronary artery disease.In the majority of patients the complaints are based on vascular dysfunction, including epicardial vascular spasms. For patients who are refractory to drug treatment, spinal cord stimulation (SCS) can be a treatment option. SCS is used for the treatment of refractory neuropathic and ischaemic pain. In recent studies the use of SCS is proven for refractory angina pectoris, but the group with refractory vasospastic angina pectoris (rVSA) predominantly seen in women with invalidating impairment of quality of life, is overlooked, as no evidence of obstruction is found at CAG. With this pilot study the investigators hypothesize that SCS is effective in reducing the number and intensity of angina attacks, reducing nitrate use, reducing inhospital treatment and ER presentations, thereby reducing medical costs, and above all, increasing quality of life.

Conditions

Angina Pectoris; Angiospastic

Keywords

ANOCA (Angina with Non-Obstructive Coronary Artery disease); Spinal Cord Stimulation; Angina Pectoris

Outcome Measures

Primary Outcomes (1)

• Seattle Angina Questionnaire (SAQ)

  For patients with coronary artery disease, the Seattle Angina Questionnaire (SAQ) has emerged as the most commonly used measure of disease-specific health status to quantify patients' symptoms of angina and the extent to which their angina affects their functioning and quality of life. Scores of 0 to 30 translate to daily angina, 31 to 60 to weekly angina, 61 to 99 to monthly angina, and 100 to no angina.

  baseline (before implant) - 1 month after implant - 3 months after implant

Secondary Outcomes (4)

• Euroquol Quality of Life questionnaire (EQ5D-5L)

  baseline (before implant) -1 month after implant - 3 months after implant

• Patient satisfaction - Numeric Rating Scale (NRS) 0-10

  1 month and 3 months after implant

• Complications and side effects

  through study completion, an average of 6 months

• Acetylcholine provocation test during coronary angiogram

  6 months after implant

Study Arms (1)

single

OTHER

Subjects are their own control

Device: Spinal Cord Stimulation

Interventions

Spinal Cord Stimulation DEVICE

Single lead placement in the posterior thoracic epidural space (T1-T4) connected to a subcutaneous battery

Also known as: Dorsal Column Stimulation

single

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• VSA is objectivated with a provocative acetylcholine test
• mentally competent and able to fill in the questionnaires
• refractory VSA defined as disabling chest pain with a maximum tolerated dosage of calcium antagonists, long acting nitrates, angiotensin converting enzyme inhibitors for a minimum of three months
• absence of obstructive coronary artery disease evident in a main coronary artery (diameter stenosis\<50%, Instant Flow Reserve (IFR) \>0.89, or Fractional Flow reserve (FFR) \>0.80)
• able to use the remote control of the SCS system

You may not qualify if:

• inability to visit the outpatient department for the follow-up visits
• unable to provide informed consent
• myocardial infarction in the previous three months
• procedures like percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), nor instability of the clinical signs and symptoms of refractory angina in the previous three months
• implanted pacemaker or implantable cardioverter-defibrillator (ICD) incompatible with SCS
• indication for ongoing anticoagulation therapy
• pregnant women and those who are breastfeeding

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Related Publications (15)

• Deer TR, Mekhail N, Provenzano D, Pope J, Krames E, Leong M, Levy RM, Abejon D, Buchser E, Burton A, Buvanendran A, Candido K, Caraway D, Cousins M, DeJongste M, Diwan S, Eldabe S, Gatzinsky K, Foreman RD, Hayek S, Kim P, Kinfe T, Kloth D, Kumar K, Rizvi S, Lad SP, Liem L, Linderoth B, Mackey S, McDowell G, McRoberts P, Poree L, Prager J, Raso L, Rauck R, Russo M, Simpson B, Slavin K, Staats P, Stanton-Hicks M, Verrills P, Wellington J, Williams K, North R; Neuromodulation Appropriateness Consensus Committee. The appropriate use of neurostimulation of the spinal cord and peripheral nervous system for the treatment of chronic pain and ischemic diseases: the Neuromodulation Appropriateness Consensus Committee. Neuromodulation. 2014 Aug;17(6):515-50; discussion 550. doi: 10.1111/ner.12208.

  PMID: 25112889 BACKGROUND

• Murphy DF, Giles KE. Dorsal column stimulation for pain relief from intractable angina pectoris. Pain. 1987 Mar;28(3):365-368. doi: 10.1016/0304-3959(87)90070-4.

  PMID: 3494978 BACKGROUND

• Mannheimer C, Eliasson T, Augustinsson LE, Blomstrand C, Emanuelsson H, Larsson S, Norrsell H, Hjalmarsson A. Electrical stimulation versus coronary artery bypass surgery in severe angina pectoris: the ESBY study. Circulation. 1998 Mar 31;97(12):1157-63. doi: 10.1161/01.cir.97.12.1157.

  PMID: 9537342 BACKGROUND

• Mobilia G, Zuin G, Zanco P, Di Pede F, Pinato G, Neri G, Cargnel S, Raviele A, Ferlin G, Buchberger R. [Effects of spinal cord stimulation on regional myocardial blood flow in patients with refractory angina. A positron emission tomography study]. G Ital Cardiol. 1998 Oct;28(10):1113-9. Italian.

  PMID: 9834863 BACKGROUND

• Dejongste MJ. Efficacy, safety and mechanisms of spinal cord stimulation used as an additional therapy for patients suffering from chronic refractory angina pectoris. Neuromodulation. 1999 Jul;2(3):188-92. doi: 10.1046/j.1525-1403.1999.00188.x. No abstract available.

  PMID: 22151207 BACKGROUND

• Lopshire JC, Zhou X, Dusa C, Ueyama T, Rosenberger J, Courtney N, Ujhelyi M, Mullen T, Das M, Zipes DP. Spinal cord stimulation improves ventricular function and reduces ventricular arrhythmias in a canine postinfarction heart failure model. Circulation. 2009 Jul 28;120(4):286-94. doi: 10.1161/CIRCULATIONAHA.108.812412. Epub 2009 Jul 13.

  PMID: 19597055 BACKGROUND

• Liu Y, Yue WS, Liao SY, Zhang Y, Au KW, Shuto C, Hata C, Park E, Chen P, Siu CW, Tse HF. Thoracic spinal cord stimulation improves cardiac contractile function and myocardial oxygen consumption in a porcine model of ischemic heart failure. J Cardiovasc Electrophysiol. 2012 May;23(5):534-40. doi: 10.1111/j.1540-8167.2011.02230.x. Epub 2011 Dec 8.

  PMID: 22151312 BACKGROUND

• Taylor RS, De Vries J, Buchser E, Dejongste MJ. Spinal cord stimulation in the treatment of refractory angina: systematic review and meta-analysis of randomised controlled trials. BMC Cardiovasc Disord. 2009 Mar 25;9:13. doi: 10.1186/1471-2261-9-13.

  PMID: 19320999 BACKGROUND

• Andrell P, Yu W, Gersbach P, Gillberg L, Pehrsson K, Hardy I, Stahle A, Andersen C, Mannheimer C. Long-term effects of spinal cord stimulation on angina symptoms and quality of life in patients with refractory angina pectoris--results from the European Angina Registry Link Study (EARL). Heart. 2010 Jul;96(14):1132-6. doi: 10.1136/hrt.2009.177188. Epub 2010 May 18.

  PMID: 20483898 BACKGROUND

• McNab D, Khan SN, Sharples LD, Ryan JY, Freeman C, Caine N, Tait S, Hardy I, Schofield PM. An open label, single-centre, randomized trial of spinal cord stimulation vs. percutaneous myocardial laser revascularization in patients with refractory angina pectoris: the SPiRiT trial. Eur Heart J. 2006 May;27(9):1048-53. doi: 10.1093/eurheartj/ehi827. Epub 2006 Mar 22.

  PMID: 16554313 BACKGROUND

• Vervaat FE, van der Gaag A, van Suijlekom H, Botman CJ, Teeuwen K, Wijnbergen I. Improvement in quality of life and angina pectoris: 1-year follow-up of patients with refractory angina pectoris and spinal cord stimulation. Neth Heart J. 2020 Sep;28(9):478-484. doi: 10.1007/s12471-020-01422-0.

  PMID: 32430654 BACKGROUND

• Gibbons RJ, Abrams J, Chatterjee K, Daley J, Deedwania PC, Douglas JS, Ferguson TB Jr, Fihn SD, Fraker TD Jr, Gardin JM, O'Rourke RA, Pasternak RC, Williams SV, Gibbons RJ, Alpert JS, Antman EM, Hiratzka LF, Fuster V, Faxon DP, Gregoratos G, Jacobs AK, Smith SC Jr; American College of Cardiology; American Heart Association Task Force on Practice Guidelines. Committee on the Management of Patients With Chronic Stable Angina. ACC/AHA 2002 guideline update for the management of patients with chronic stable angina--summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients With Chronic Stable Angina). Circulation. 2003 Jan 7;107(1):149-58. doi: 10.1161/01.cir.0000047041.66447.29. No abstract available.

  PMID: 12515758 BACKGROUND

• Suwaidi JA, Hamasaki S, Higano ST, Nishimura RA, Holmes DR Jr, Lerman A. Long-term follow-up of patients with mild coronary artery disease and endothelial dysfunction. Circulation. 2000 Mar 7;101(9):948-54. doi: 10.1161/01.cir.101.9.948.

  PMID: 10704159 BACKGROUND

• Deer T, Slavin KV, Amirdelfan K, North RB, Burton AW, Yearwood TL, Tavel E, Staats P, Falowski S, Pope J, Justiz R, Fabi AY, Taghva A, Paicius R, Houden T, Wilson D. Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform. Neuromodulation. 2018 Jan;21(1):56-66. doi: 10.1111/ner.12698. Epub 2017 Sep 29.

  PMID: 28961366 BACKGROUND

• Chakravarthy K, Kent AR, Raza A, Xing F, Kinfe TM. Burst Spinal Cord Stimulation: Review of Preclinical Studies and Comments on Clinical Outcomes. Neuromodulation. 2018 Jul;21(5):431-439. doi: 10.1111/ner.12756. Epub 2018 Feb 12.

  PMID: 29431275 BACKGROUND

MeSH Terms

Conditions

Angina Pectoris

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Markus Hollmann, MD, PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frank Wille, MD

CONTACT

00-31-20-5662303; f.wille@msterdamumc.nl

Matthanja Bieze, MD, PhD

CONTACT

00-31-20-5662303; m.bieze@msterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective pilot study

Study Record Dates

• First Submitted: November 26, 2023
• First Posted: December 19, 2023
• Study Start: January 2, 2024
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 6 months after closure of database for 3 years
• Access Criteria: On request