Obstructive Coronary Artery DiseaseHYSTERESISNCT07847463
Can Exercise Electrocardiography Discriminate Hypertensive Heart Disease From Obstructive Coronary Artery Disease? A Multimodality Imaging Study
An observational study of Obstructive Coronary Artery Disease and Left Ventricular Hypertrophy, run by University of Pisa at 1 site in Italy.
Trial summary
To evaluate the ability of exercise ECG to discriminate between hypertensive heart disease-related and CAD-related abnormalities Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Obstructive Coronary Artery Disease, Left Ventricular Hypertrophy
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2026to 1 Sep 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: consecutive patients undergoing evaluation for suspected coronary artery disease will undergo exercise ECG testing (ExECG), transthoracic echocardiography (TTE), stress cardiac magnetic resonance (CMR), and coronary computed tomography angiography (CCTA). Patients will be stratified into four groups according to the presence or absence of LVH and obstructive CAD: LVH with obstructive CAD LVH without obstructive CAD No LVH with obstructive CAD No LVH without obstructive CAD
Who may be able to join
- Patients with CAD and LVH
Who cannot join
- Patients with RBBB
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria Pisana
Pisa, PI, 56124
Mattia Alberti, MD, PhD candidate, +39 3770805335, mattia.alberti@phd.unipi.it
Morrone Doralisa, MD, PhD, Associate Professor, doralisa.morrone@unipi.it
About this study
To evaluate the ability of exercise ECG to discriminate between hypertensive heart disease-related and CAD-related abnormalities
Read the detailed description
In this prospective study, consecutive patients undergoing evaluation for suspected coronary artery disease will undergo exercise ECG testing (ExECG), transthoracic echocardiography (TTE), stress cardiac magnetic resonance (CMR), and coronary computed tomography angiography (CCTA).
Patients will be stratified into four groups according to the presence or absence of LVH and obstructive CAD:
LVH with obstructive CAD LVH without obstructive CAD No LVH with obstructive CAD No LVH without obstructive CAD
LVH will be defined by standard echocardiographic criteria, while obstructive CAD will be assessed by CCTA. Stress CMR will serve as the reference standard for inducible myocardial ischemia.
Exercise ECG parameters will include conventional ST-segment criteria as well as dynamic indices during exercise and recovery. Associations between ECG findings and imaging-defined phenotypes will be evaluated, and predictors of CAD-related ischemia will be identified.
Results The study will assess the diagnostic performance of exercise ECG across the four predefined groups. Differences in ECG response patterns will be compared according to the presence of LVH and obstructive CAD. Multivariable analysis will be performed to identify independent ECG predictors associated with obstructive CAD and inducible ischemia.
- Keywords
- exercise ECG, LVH, CCTA, Stress CMR, CAD, transthoracic echocardiography, TTE
- Medical subject headings
- Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| LVH with obstructive CAD | LVH with obstructive CAD | |
| LVH without obstructive CAD | LVH without obstructive CAD | |
| No LVH with obstructive CAD | No LVH with obstructive CAD | |
| No LVH without obstructive CAD | No LVH without obstructive CAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic performance of exercise ECG across the four predefined groups.
Differences in ECG response patterns will be compared according to the presence of LVH and obstructive CAD. Multivariable analysis will be performed to identify independent ECG predictors associated with obstructive CAD and inducible ischemia.
Measured: From enrollment through completion of all diagnostic evaluations, assessed up to 3 months after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Sep 2026
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mattia Alberti, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847463
- Sponsor's protocol ID
- HYSTERESIS
- Acronym
- HYSTERESIS
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will be made available upon reasonable request following the completion of all planned analyses and subsequent publication of the resulting manuscripts
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Exercise Electrocardiography Discriminate Hypertensive Heart Disease From Obstructive Coronary Artery Disease? A Multimodality Imaging Study
- ClinicalTrials.gov ID
- NCT07847463
- Acronym / sponsor ID
- HYSTERESIS / HYSTERESIS
- Keywords
- exercise ECG, LVH, CCTA, Stress CMR, CAD, transthoracic echocardiography, TTE
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 29 Sep 2026 (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.
To evaluate the ability of exercise ECG to discriminate between hypertensive heart disease-related and CAD-related abnormalities
Detailed description
In this prospective study, consecutive patients undergoing evaluation for suspected coronary artery disease will undergo exercise ECG testing (ExECG), transthoracic echocardiography (TTE), stress cardiac magnetic resonance (CMR), and coronary computed tomography angiography (CCTA).
Patients will be stratified into four groups according to the presence or absence of LVH and obstructive CAD:
LVH with obstructive CAD LVH without obstructive CAD No LVH with obstructive CAD No LVH without obstructive CAD
LVH will be defined by standard echocardiographic criteria, while obstructive CAD will be assessed by CCTA. Stress CMR will serve as the reference standard for inducible myocardial ischemia.
Exercise ECG parameters will include conventional ST-segment criteria as well as dynamic indices during exercise and recovery. Associations between ECG findings and imaging-defined phenotypes will be evaluated, and predictors of CAD-related ischemia will be identified.
Results The study will assess the diagnostic performance of exercise ECG across the four predefined groups. Differences in ECG response patterns will be compared according to the presence of LVH and obstructive CAD. Multivariable analysis will be performed to identify independent ECG predictors associated with obstructive CAD and inducible ischemia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LVH with obstructive CAD | – | –LVH with obstructive CAD |
| LVH without obstructive CAD | – | –LVH without obstructive CAD |
| No LVH with obstructive CAD | – | –No LVH with obstructive CAD |
| No LVH without obstructive CAD | – | –No LVH without obstructive CAD |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive patients undergoing evaluation for suspected coronary artery disease will undergo exercise ECG testing (ExECG), transthoracic echocardiography (TTE), stress cardiac magnetic resonance (CMR), and coronary computed tomography angiography (CCTA). Patients will be stratified into four groups according to the presence or absence of LVH and obstructive CAD: LVH with obstructive CAD LVH without obstructive CAD No LVH with obstructive CAD No LVH without obstructive CAD
Key inclusion criteria (1 listed)
- Patients with CAD and LVH
Key exclusion criteria (1 listed)
- Patients with RBBB
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
diagnostic performance of exercise ECG across the four predefined groups.
Time frame: From enrollment through completion of all diagnostic evaluations, assessed up to 3 months after enrollment.
Differences in ECG response patterns will be compared according to the presence of LVH and obstructive CAD. Multivariable analysis will be performed to identify independent ECG predictors associated with obstructive CAD and inducible ischemia.
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 29 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will be made available upon reasonable request following the completion of all planned analyses and subsequent publication of the resulting manuscripts
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Coronary Artery Disease and Left Ventricular Hypertrophy, run by University of Pisa at 1 site in Italy.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 29 Sep 2026. 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 Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic performance of exercise ECG across the four predefined groups. (time frame: From enrollment through completion of all diagnostic evaluations, assessed up to 3 months after enrollment.). 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 29 Sep 2026.