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| ID | Type | Description | Link |
|---|---|---|---|
| 20240124 | Other Identifier | JohannesGU |
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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:
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:
1. Agreement and reproducibility between intravenous and intracoronary adenosine administration in the IMR value.
Secondary endpoints:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Adenosine | Active Comparator | Invasive microvascular function assessment will be conducted by administering intravenous hyperemic agent adenosine. |
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| Intracoronary Adenosine | Experimental | Invasive microvascular function assessment will be conducted by administering intracoronary hyperemic agent adenosine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| microvascular function assessment | Diagnostic Test | mircovascular function parameters will be measured by administering adenosine in two different pathways |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tommaso Gori, MD, PhD | Contact | 00496131172829 | tomgori@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Tommaso Gori, MD,PhD | Center of Cardiology, Cardiology I, University Medical Center Mainz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of Cardiology, Cardiology I, university hospital Mainz | Mainz | Rhineland-Palatinate | 55131 | Germany |
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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).
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Patients and outcome assessors will be blinded to the randomization group.
| Time required for IMR measurements | Comparison of time required for measuring IMR between intracoronary and intravenous adenosine administration | 6 months |