search
Back to results

ReACHallenge Trial: Acetylcholine Rechallenge After Pretreatment With Vasoactive Drugs (ReACHallenge)

Primary Purpose

Angina Pectoris, Variant, Angina Pectoris; Spasm-Induced, Angina Pectoris With Normal Coronary Arteriogram

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Acetylcholine rechallenge
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Angina Pectoris, Variant focused on measuring Vasospastic angina, Angina with non-obstructive coronary arteries (ANOCA), Acetylcholine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 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.

Sites / Locations

  • University Hospital AntwerpRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vasospastic angina

Arm Description

Interventional diagnostic protocol

Outcomes

Primary Outcome Measures

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?
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?

Secondary Outcome Measures

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?
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?

Full Information

First Posted
November 8, 2022
Last Updated
January 17, 2023
Sponsor
University Hospital, Antwerp
search

1. Study Identification

Unique Protocol Identification Number
NCT05618132
Brief Title
ReACHallenge Trial: Acetylcholine Rechallenge After Pretreatment With Vasoactive Drugs
Acronym
ReACHallenge
Official Title
Stepwise Treatment and Acetylcholine Rechallenge in Vasospastic Angina to Guide Patient-tailored Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Antwerp

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina Pectoris, Variant, Angina Pectoris; Spasm-Induced, Angina Pectoris With Normal Coronary Arteriogram
Keywords
Vasospastic angina, Angina with non-obstructive coronary arteries (ANOCA), Acetylcholine

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vasospastic angina
Arm Type
Experimental
Arm Description
Interventional diagnostic protocol
Intervention Type
Diagnostic Test
Intervention Name(s)
Acetylcholine rechallenge
Intervention Description
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).
Primary Outcome Measure Information:
Title
The percent of ACH provoked spasm that is no longer inducible by ACH after IC injection of verapamil.
Description
Is verapamil able to suppress ACH-induced coronary artery spasm?
Time Frame
Baseline
Title
The percent of ACH provoked spasm that is no longer inducible by ACH after sequential IC injection of verapamil and NTG.
Description
Is verapamil + NTG able to suppress ACH-induced coronary artery spasm?
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
The percent of ACH provoked spasm that resolves after IC administration of verapamil.
Description
How efficient is verapamil IC as a treatment for ACH-induced coronary artery spasm?
Time Frame
Baseline
Title
The percent of ACH provoked spasm that resolves after sequential IC administration of verapamil and NTG.
Description
How efficient is verapamil and NTG IC as a treatment for ACH-induced coronary artery spasm?
Time Frame
Baseline
Other Pre-specified Outcome Measures:
Title
Proportion of patients with epicardial coronary artery spasm who have microvascular spasm after either verapamil or verapamil + NTG.
Description
Do microvascular and epicardial vasospasm occur simultaneously and is it possible to unmask microvascular spasm with either verapamil or verapamil + NTG.
Time Frame
Baseline
Title
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Description
Are there safety concerns related to the proposed ACH rechallenge protocol?
Time Frame
Baseline
Title
Absolute changes in the individual, overall and summary score of the Seattle Angina Questionnaire (SAQ) from baseline to the first ambulatory control visit.
Description
Does treatment based on the current protocol improve control of angina at the first ambulatory visit compared to before the coronary function tests?
Time Frame
Baseline, 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tijs Bringmans
Phone
+32 3 821 3843
Email
tijs.bringmans@uza.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tijs Bringmans
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Antwerp
City
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tijs Bringmans
Email
tijs.bringmans@uza.be
First Name & Middle Initial & Last Name & Degree
Vincent FM Segers

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

ReACHallenge Trial: Acetylcholine Rechallenge After Pretreatment With Vasoactive Drugs

We'll reach out to this number within 24 hrs