SCS for Vasospastic Angina Vasospastic Angina Pectoris - a Prospective Study (VAP)

December 9, 2023 updated by: Frank Wille, MD, Amsterdam UMC, location VUmc

Spinal Cord Stimulation for Vasospastic Angina Pectoris - a Prospective Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Rationale:

Of the patients undergoing a coronary angiogram because of chest pain (AP), 67% of female and 33% of male patients have no obstructive coronary artery disease. In the majority of patients (59-89%) the complaints are based on vascular dysfunction, including epicardial vascular spasms (EVS). 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 effective 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 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.

Objective: the main objective of this study is to evaluate the clinical effects of SCS on the number and intensity of VSA attacks. Secondary objective is to objectivate the effects of SCS on coronary spasms during the provocative acetylcholine test, and assess medical costs, patient satisfaction and quality of life.

Study design: prospective study in two phases. Phase 1: evaluation of clinical effectiveness. Phase 2: evaluation of SCS on vascular spasms during acetylcholine provocation test.

Study population: 10 patients with refractory AP due to epicardial vascular spasms.

Intervention: implantation with a SCS device with one or two lead(s) in the epidural space of T1 to T4, active electrodes depending on mapping of the painfull area, under local anesthesia and sedation. Acetylcholine provocation test during coronary angiogram at 6 months.

Main study parameters/endpoints: primary endpoint is the Seattle Angina Questionnaire (SAQ) at month 1 and 3. Secundary endpoints are presentation at ER, estimated medical costs, and patient satisfaction measured on a 11 point Numeric Rating Scale and quality of life with the EQ5D at month 3, compared to baseline. Endpoints of the acetylcholine test are changes in coronary flow and coronary diameter compared to baseline.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: SCS is proven to be safe for neuropathic and ischaemic pain and is widely used in clinical practice. With the positive results of an ongoing clinical trial for refractory coronary angina, the investigators estimate the efficacy of SCS to be around 80-90% in reducing VSA attacks with 50% after 3 months and therefore very effective in otherwise refractory drug treatment regiments. Furthermore, baseline study parameters will be extracted from the routine questionnaires and during visits to the outpatient clinic.

Only in patients who specifically consent to it, an additional acetylcholine test 6 months after SCS implantation during coronary angiography (CAG) is performed. This is an additional coronary angiogram procedure under local anesthesia which potentially provokes VSA. Done by experienced personal this is a safe test with a complication risk of 0-0.7% for severe cardiac complications, comparable to coronary angiogram with functional flow reserve measurement.

A potential benefit for the participants is that SCS results in reduction of VSA attacks, reduction of nitrate use, less presentation at an ER, an improved quality of life, and acceptation as standard treatment.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: single
Subjects are their own control
Device: Spinal Cord Stimulation
Single lead placement in the posterior thoracic epidural space (T1-T4) connected to a subcutaneous battery
Other Names:
  • Dorsal Column Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seattle Angina Questionnaire (SAQ)
Time Frame: baseline (before implant) - 1 month after implant - 3 months after implant

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Euroquol Quality of Life questionnaire (EQ5D-5L)
Time Frame: baseline (before implant) -1 month after implant - 3 months after implant

The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems. In addition, there is a visual analogue scale (VAS) to indicate the general health status with 100 indicating the best health status.
baseline (before implant) -1 month after implant - 3 months after implant
Patient satisfaction - Numeric Rating Scale (NRS) 0-10
Time Frame: 1 month and 3 months after implant
11-point Likert-type scale
1 month and 3 months after implant
Complications and side effects
Time Frame: through study completion, an average of 6 months
Related to SCS
through study completion, an average of 6 months
Acetylcholine provocation test during coronary angiogram
Time Frame: 6 months after implant
Test to objectivate coronary spasms (compared to baseline)
6 months after implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amsterdam UMC, location VUmc

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

  • Principal Investigator: Markus Hollmann, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 2, 2024

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

November 26, 2023

First Submitted That Met QC Criteria

December 9, 2023

First Posted (Estimated)

December 19, 2023

Study Record Updates

Last Update Posted (Estimated)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 9, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL79947.018.21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In progress

IPD Sharing Time Frame

6 months after closure of database for 3 years

IPD Sharing Access Criteria

On request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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