Microvascular Coronary Artery DiseaseASPERA-ANOCANCT06269874
Study Comparing Two Administration Pathways for Adenosine During Microvascular Function Assessment
A study testing microvascular function assessment in people with Microvascular Coronary Artery Disease, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
The aim of this study is to investigate the agreement and reproducibility between intravenous and intracoronary adenosine administration during invasive assessment of microvascular function. Goals of this study are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microvascular Coronary Artery Disease
- What is being tested?
- microvascular function assessment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 2 Mar 2027to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Chronic coronary syndrome (including patients with anginal equivalents).
- Indication to cardiac catheterization;
- Indication to the assessment of microvascular function (note: patients will be asked for participation and consented prior to the first measurement of microvascular function, which will be conducted as per clinical indication)
- Willingness to participate and ability to understand, read and sign the informed consent
- Age>18 years
Who cannot join
- Age <18 years
- Bronchial asthma, COPD (chronic obstructive pulmonary disease)
- Secondary or tertiary atrioventricular block without prior pacemaker implantation
- Previous CABG (coronary artery bypass graft) with patent grafts to the left anterior descending coronary
- Epicardial coronary disease (FFR <0.80 with evidence of a focal stenosis) in the left anterior descending territory
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Center of Cardiology, Cardiology I, university hospital Mainz
Mainz, Rhineland-Palatinate, 55131
About this study
Official title: A Single-centric, ProspectivE, Randomized Controlled Study Comparing Two Administration Pathways for Adenosine During Invasive Assessment of Microvascular Function in Patients With ANOCA.
The aim of this study is to investigate the agreement and reproducibility between intravenous and intracoronary adenosine administration during invasive assessment of microvascular function.
Goals of this study are:
- Agreement and reproducibility between intravenous and intracoronary adenosine administration in the IMR (Index of microvascular resistance) value.
- Agreement and reproducibility of FFR(fractional flow reserve), CFR (coronary flow reserve), MRR (microvascular resistance reserve), RRR (resistive reserve ratio) and reproducibility of each of these as compared with CFRabs (absolute coronary flow).
- Time required for IMR measurements
Read the detailed description
The study is a single-center randomized, cross-over controlled, open label trial to investigate the reproducibility and agreement between intravenous and intracoronary adenosine administration during invasive assessment of microvascular function.
The primary analysis will be on the per-protocol population (i.e. including all patients who are not protocol violators).
Primary endpoint:
- Agreement and reproducibility between intravenous and intracoronary adenosine administration in the IMR value.
Secondary endpoints:
- Agreement and reproducibility of FFR, CFR, MRR, RRR and reproducibility of each of these as compared with CFRabs.
- Time required for IMR measurements
- Presence and severity of angina, assessed by SAQ(Seattle Angina Questionnaire)-7
- Assessment of safety: Presence and severity of AV( atrioventricular) block, dyspnea, flush
- Conditions
- Microvascular Coronary Artery Disease
- Being tested
- microvascular function assessment
- Keywords
- adenosine, coronary microvascular assessment, microvascular disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microvascular function assessmentDiagnostic test
mircovascular function parameters will be measured by administering adenosine in two different pathways
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Adenosine | Active comparator | Invasive microvascular function assessment will be conducted by administering intravenous hyperemic agent adenosine. Receives: Diagnostic Test: microvascular function assessment |
| Intracoronary Adenosine | Experimental | Invasive microvascular function assessment will be conducted by administering intracoronary hyperemic agent adenosine. Receives: Diagnostic Test: microvascular function assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between intravenous and intracoronary adenosine responses (IMR)
Agreement and reproducibility between IMR (index of microvascular resistance) obtained with intravenous and intracoronary adenosine administration during invasive assessment of microvascular function as assessed by Cohen´s Kappa, intraclass correlation coefficient and Bland-Altman analysis.
Measured: 6 months
Secondary outcomes (2)
Agreement between secondary parameters and reproducibility as compared with absolute
Agreement and reproducibility between secondary parameters (MRR, RRR, Pd/Pa, FFR, CFR, Ach-IMR) obtained with intravenous and intracoronary adenosine administration during invasive assessment of microvascular function as assessed by Cohen´s Kappa, intraclass correlation coefficient and Bland-Altman analysis.
Measured: 6 months
Time required for IMR measurements
Comparison of time required for measuring IMR between intracoronary and intravenous adenosine administration
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start2 Mar 2027 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microvascular Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized 1:1 to one of the two study arms and then the following study procedures will repeated in cross-over. Randomization will be done by using a computer-generated random sequence (medcalc, mariakerke, BE).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tommaso Gori, Johannes Gutenberg University Mainz
- Investigators
- Tommaso Gori, MD,PhD, Principal investigator, Center of Cardiology, Cardiology I, University Medical Center Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269874
- Sponsor's protocol ID
- ASPERA-ANOCA
- Other IDs
- 20240124
- Acronym
- ASPERA-ANOCA
- Status last verified
- Oct 2024
- First submitted
- 13 Feb 2024
- Last updated
- 8 Oct 2024
- 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 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centric, ProspectivE, Randomized Controlled Study Comparing Two Administration Pathways for Adenosine During Invasive Assessment of Microvascular Function in Patients With ANOCA.
- ClinicalTrials.gov ID
- NCT06269874
- Acronym / sponsor ID
- ASPERA-ANOCA / ASPERA-ANOCA
- Conditions
- Microvascular Coronary Artery Disease
- Keywords
- adenosine, coronary microvascular assessment, microvascular disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 2 Mar 2027 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 21 Feb 2024 (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 aim of this study is to investigate the agreement and reproducibility between intravenous and intracoronary adenosine administration during invasive assessment of microvascular function.
Goals of this study are:
- Agreement and reproducibility between intravenous and intracoronary adenosine administration in the IMR (Index of microvascular resistance) value.
- Agreement and reproducibility of FFR(fractional flow reserve), CFR (coronary flow reserve), MRR (microvascular resistance reserve), RRR (resistive reserve ratio) and reproducibility of each of these as compared with CFRabs (absolute coronary flow).
- Time required for IMR measurements
Detailed description
The study is a single-center randomized, cross-over controlled, open label trial to investigate the reproducibility and agreement between intravenous and intracoronary adenosine administration during invasive assessment of microvascular function.
The primary analysis will be on the per-protocol population (i.e. including all patients who are not protocol violators).
Primary endpoint:
- Agreement and reproducibility between intravenous and intracoronary adenosine administration in the IMR value.
Secondary endpoints:
- Agreement and reproducibility of FFR, CFR, MRR, RRR and reproducibility of each of these as compared with CFRabs.
- Time required for IMR measurements
- Presence and severity of angina, assessed by SAQ(Seattle Angina Questionnaire)-7
- Assessment of safety: Presence and severity of AV( atrioventricular) block, dyspnea, flush
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized 1:1 to one of the two study arms and then the following study procedures will repeated in cross-over. Randomization will be done by using a computer-generated random sequence (medcalc, mariakerke, BE).
| Arm | Type | Receives |
|---|---|---|
| Intravenous Adenosine | Active comparator | Diagnostic Test: microvascular function assessmentInvasive microvascular function assessment will be conducted by administering intravenous hyperemic agent adenosine. |
| Intracoronary Adenosine | Experimental | Diagnostic Test: microvascular function assessmentInvasive microvascular function assessment will be conducted by administering intracoronary hyperemic agent adenosine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic coronary syndrome (including patients with anginal equivalents).
- Indication to cardiac catheterization;
- Indication to the assessment of microvascular function (note: patients will be asked for participation and consented prior to the first measurement of microvascular function, which will be conducted as per clinical indication)
- Willingness to participate and ability to understand, read and sign the informed consent
- Age>18 years
Key exclusion criteria (6 listed)
- Age <18 years
- Bronchial asthma, COPD (chronic obstructive pulmonary disease)
- Secondary or tertiary atrioventricular block without prior pacemaker implantation
- Previous CABG (coronary artery bypass graft) with patent grafts to the left anterior descending coronary
- Epicardial coronary disease (FFR <0.80 with evidence of a focal stenosis) in the left anterior descending territory
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 |
|---|---|---|
| microvascular function assessmentmircovascular function parameters will be measured by administering adenosine in two different pathways | Diagnostic test | Intracoronary Adenosine, Intravenous Adenosine |
Primary outcome
Agreement between intravenous and intracoronary adenosine responses (IMR)
Time frame: 6 months
Agreement and reproducibility between IMR (index of microvascular resistance) obtained with intravenous and intracoronary adenosine administration during invasive assessment of microvascular function as assessed by Cohen´s Kappa, intraclass correlation coefficient and Bland-Altman analysis.
2 secondary outcomes
Agreement between secondary parameters and reproducibility as compared with absolute
Time frame: 6 months
Time required for IMR measurements
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Tommaso Gori, MD,PhD principal investigator
Center of Cardiology, Cardiology I, University Medical Center Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microvascular function assessment in people with Microvascular Coronary Artery Disease, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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 6 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: opening soon, as of the sponsor's last update on 8 Oct 2024. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tommaso Gori, MD, PhD (00496131172829, tomgori@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between intravenous and intracoronary adenosine responses (IMR) (time frame: 6 months). 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 8 Oct 2024.