Angina Pectoris, VariantReACHallengeNCT05618132
ReACHallenge Trial: Acetylcholine Rechallenge After Pretreatment With Vasoactive Drugs
A study testing Acetylcholine rechallenge in people with Angina Pectoris, Variant and Angina Pectoris; Spasm-Induced, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
The goal of this clinical trial is to assess the feasibility and clinical value of acetylcholine (ACH) rechallenge after intracoronary verapamil +- nitroglycerine in a patient cohort with angina and non-obstructive coronary arteries (ANOCA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina Pectoris, Variant, Angina Pectoris; Spasm-Induced, Angina Pectoris With Normal Coronary Arteriogram
- What is being tested?
- Acetylcholine rechallenge
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Jan 2023to 1 Jun 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically indicated coronary angiogram in the setting of angina with non-obstructive coronary artery disease (ANOCA)
- Non-obstructive coronary artery disease is defined as the absence of coronary artery stenosis ≥ 50%, or if ≥ 50% with non-ischemic resting (RFR > 0.89) and hyperemic indices (FFR > 0.80).
- ACH provoked epicardial and/or microvascular spasm
- Left ventricular ejection fraction (LVEF) > 50%
- Renal function with eGFR ≥ 40 ml/min
Who cannot join
- Obstructive coronary artery disease (both chronic and acute coronary coronary syndromes)
- Any cardiomyopathy (including takotsubo stress cardiomyopathy) or severe valvular disease
- LVEF < 50%
- Long QT syndrome (LQTS) - genetic or acquired
- Ventricular paced rhythm
- Renal failure with eGFR < 40 ml/min
Show all 9Show fewer
- Thyroid stimulating hormone (TSH) < lower limit of normal (LLN). A subject taking thyroid replacement therapy may be enrolled with TSH level below LLN if, in the opinion of the investigator, the subject is in a clinically euthyroid state.
- Known hypersensitivity or contra-indication for either acetylcholine, verapamil, nicorandil or nitroglycerine.
- Pregnant female subjects. Female subjects of child-bearing potential should be on adequate contraceptive measures or are to be screened with a urine pregnancy test.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Antwerp
Antwerp, 2650
Tijs Bringmans, tijs.bringmans@uza.be
Vincent FM Segers
About this study
Official title: Stepwise Treatment and Acetylcholine Rechallenge in Vasospastic Angina to Guide Patient-tailored Treatment
The goal of this clinical trial is to assess the feasibility and clinical value of acetylcholine (ACH) rechallenge after intracoronary verapamil +- nitroglycerine in a patient cohort with angina and non-obstructive coronary arteries (ANOCA).
The main questions it aims to answer are:
- to determine the efficacy of these drugs in treating ACH-induced coronary artery spasm
- to determine the efficacy of these drugs in preventing ACH-induced coronary artery spasm
The ACH rechallenge will take place during the index coronary function tests in patients with proven ACH-induced vasospastic angina. The study is considered a feasibility study, no control arm is included.
- Conditions
- Angina Pectoris, Variant, Angina Pectoris; Spasm-Induced, Angina Pectoris With Normal Coronary Arteriogram
- Being tested
- Acetylcholine rechallenge
- Keywords
- Vasospastic angina, Angina with non-obstructive coronary arteries (ANOCA), Acetylcholine
- Medical subject headings
- Angina Pectoris, Variant, Angina Pectoris, Microvascular Angina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylcholine rechallengeDiagnostic test
STEP 1 consists of verapamil 1mg IC. Angiography after 60 seconds, if spasm persists, NTG 200µg IC is given (step 2). If verapamil suppresses spasm, ACH rechallenge (ACHR) is performed after 3 minutes.
In STEP 2, patients with persistent spasm after verapamil or with spasm after ACHR receive NTG 200µg IC. Angiography after 60 seconds, if spasm persists, NTG 200µg IC is delivered again. If refractory spasm occurs, atropine 1mg IV is given. Coronary spasm is considered suppressed once ACHR can no longer provoke spasm. NTG 200µg IC is given as final drug regardless of spasm.
ACHR consists of ACH 100 or 200µg IC depending on the dose that previously provoked the coronary artery spasm (both microvascular and epicardial spasm).
| Study group | Role | What they receive |
|---|---|---|
| Vasospastic angina | Experimental | Interventional diagnostic protocol Receives: Diagnostic Test: Acetylcholine rechallenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent of ACH provoked spasm that is no longer inducible by ACH after IC injection of verapamil.
Is verapamil able to suppress ACH-induced coronary artery spasm?
Measured: Baseline
The percent of ACH provoked spasm that is no longer inducible by ACH after sequential IC injection of verapamil and NTG.
Is verapamil + NTG able to suppress ACH-induced coronary artery spasm?
Measured: Baseline
Secondary outcomes (2)
The percent of ACH provoked spasm that resolves after IC administration of verapamil.
How efficient is verapamil IC as a treatment for ACH-induced coronary artery spasm?
Measured: Baseline
The percent of ACH provoked spasm that resolves after sequential IC administration of verapamil and NTG.
How efficient is verapamil and NTG IC as a treatment for ACH-induced coronary artery spasm?
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start9 Jan 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina Pectoris, VariantStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tijs Bringmans, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618132
- Sponsor's protocol ID
- 2806
- Acronym
- ReACHallenge
- Status last verified
- Oct 2022
- First submitted
- 8 Nov 2022
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepwise Treatment and Acetylcholine Rechallenge in Vasospastic Angina to Guide Patient-tailored Treatment
- ClinicalTrials.gov ID
- NCT05618132
- Acronym / sponsor ID
- ReACHallenge / 2806
- Conditions
- Angina Pectoris, Variant, Angina Pectoris; Spasm-Induced, Angina Pectoris With Normal Coronary Arteriogram
- Keywords
- Vasospastic angina, Angina with non-obstructive coronary arteries (ANOCA), Acetylcholine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 16 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to assess the feasibility and clinical value of acetylcholine (ACH) rechallenge after intracoronary verapamil +- nitroglycerine in a patient cohort with angina and non-obstructive coronary arteries (ANOCA).
The main questions it aims to answer are:
- to determine the efficacy of these drugs in treating ACH-induced coronary artery spasm
- to determine the efficacy of these drugs in preventing ACH-induced coronary artery spasm
The ACH rechallenge will take place during the index coronary function tests in patients with proven ACH-induced vasospastic angina. The study is considered a feasibility study, no control arm is included.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vasospastic angina | Experimental | Diagnostic Test: Acetylcholine rechallengeInterventional diagnostic protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinically indicated coronary angiogram in the setting of angina with non-obstructive coronary artery disease (ANOCA)
- Non-obstructive coronary artery disease is defined as the absence of coronary artery stenosis ≥ 50%, or if ≥ 50% with non-ischemic resting (RFR > 0.89) and hyperemic indices (FFR > 0.80).
- ACH provoked epicardial and/or microvascular spasm
- Left ventricular ejection fraction (LVEF) > 50%
- Renal function with eGFR ≥ 40 ml/min
Key exclusion criteria (9 listed)
- Obstructive coronary artery disease (both chronic and acute coronary coronary syndromes)
- Any cardiomyopathy (including takotsubo stress cardiomyopathy) or severe valvular disease
- LVEF < 50%
- Long QT syndrome (LQTS) - genetic or acquired
- Ventricular paced rhythm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetylcholine rechallengeSTEP 1 consists of verapamil 1mg IC. Angiography after 60 seconds, if spasm persists, NTG 200µg IC is given (step 2). If verapamil suppresses spasm, ACH rechallenge (ACHR) is performed after 3 minutes. In STEP 2, patients with persistent spasm after verapamil or with spasm after ACHR receive NTG 200µg IC. Angiography after 60 seconds, if spasm persists, NTG 200µg IC is delivered again. If refractory spasm occurs, atropine 1mg IV is given. Coronary spasm is considered suppressed once ACHR can no longer provoke spasm. NTG 200µg IC is given as final drug regardless of spasm. ACHR consists of ACH 100 or 200µg IC depending on the dose that previously provoked the coronary artery spasm (both microvascular and epicardial spasm). | Diagnostic test | Vasospastic angina |
Primary outcome
The percent of ACH provoked spasm that is no longer inducible by ACH after IC injection of verapamil.
Time frame: Baseline
Is verapamil able to suppress ACH-induced coronary artery spasm?
The percent of ACH provoked spasm that is no longer inducible by ACH after sequential IC injection of verapamil and NTG.
Time frame: Baseline
Is verapamil + NTG able to suppress ACH-induced coronary artery spasm?
2 secondary outcomes
The percent of ACH provoked spasm that resolves after IC administration of verapamil.
Time frame: Baseline
The percent of ACH provoked spasm that resolves after sequential IC administration of verapamil and NTG.
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Angina Pectoris, Variant
Recruiting
Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women
ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
RecruitingObservational study
Gangwon PCI Prospective Registry
Coronary Artery Disease, Ischemic Heart Disease (IHD)
RecruitingPhase 4
Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Variant Angina Manifesting as Aborted Sudden Cardiac Death
Angina Pectoris, Variant, Sudden Cardiac Death
Recruiting
iCorMicA - Stratified Medicine in Angina
Microvascular Angina, Angina, Stable
Active, not recruiting
Cardioneuroablation for Variant Angina
Variant Angina
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tijs Bringmans principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetylcholine rechallenge in people with Angina Pectoris, Variant and Angina Pectoris; Spasm-Induced, run by University Hospital, Antwerp at 1 site in Belgium.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 19 Jan 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tijs Bringmans (+32 3 821 3843, tijs.bringmans@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percent of ACH provoked spasm that is no longer inducible by ACH after IC injection of verapamil. (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2023.