Peripheral Arterial DiseasePhase 3NCT00189111
Non-invasive Cardiac Screening in High Risk Patients -The GROUND Study
A Phase 3 study testing Cardiac Imaging + Treatment in people with Peripheral Arterial Disease, run by Clinical Research Office Imaging Division at 5 sites in Netherlands.
Trial summary
The purpose of this study is to find out if subjecting cardiac high risk patients to non invasive cardiac imaging, followed by treatment will improve survival and quality of life Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Cardiac Imaging + Treatment
- Type of treatment
- Surgery or procedure
- How many people
- 1,200 participants
- Where
- 5 sitesNetherlands
- Study dates
- Jan 2005to Apr 2012
- Phase
- Phase 3
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with peripheral arterial disease, diagnosed by the vascular surgeon
- Patients must provide consent in writing after proper education and discussion with the treating physician and/or research physician
- Patients must be aged 50 years or over
Who cannot join
- History of symptomatic cardiac disease
- Cardiac rhythm other than sinus
- Unable to sustain a breath-hold for 25 seconds
- Asthma (contraindication beta-blockers)
- Contra-indications to MRI examination.
- Contra-indications to iodine contrast.
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- Severe arterial hypertension (>220/120 mmHg)
- Significant aortic stenosis
- Unable to remain in supine position for at least 60 minutes
- Morbidly obese (BMI > 40)
- Renal insufficiency (creatinine >140mmol/l)
- Severe physical deterioration due to concomitant illness
- Language barrier
- Acute coronary syndrome
- Contra-indications to dobutamine
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Netherlands5 sites
Meander Medical Center
Amersfoort, Utrecht, 3800 BM
University Medical Center Groningen
Groningen, 9700 RB
St. Antonius Hospital
Nieuwegein, Utrecht, 3435 CM
Bronovo Hospital
The Hague, South Holland, 2597 AX
University Medical Center Utrecht
Utrecht, 3584CX
About this study
The purpose of this study is to find out if subjecting cardiac high risk patients to non invasive cardiac imaging, followed by treatment will improve survival and quality of life
Read the detailed description
Peripheral arterial disease (PAD) is a common disease associated with a considerably increased risk of future events and with a high prevalence of coronary artery disease (CAD). Improvement of the prognosis of this patient group is needed. Screening for CAD has become an option with recent developments in CT-angiography and MR stress testing. It is unknown if high-risk patient groups benefit from screening through non-invasive cardiac imaging. Therefore we propose to study whether a cardiac imaging algorithm, using non-invasive imaging techniques followed by evidence-based treatment will reduce the risk of cardiovascular disease in cardiac asymptomatic PAD patients.
The GROUND study is designed as a prospective, multi-center, randomized clinical trial. Patients with peripheral arterial disease, but yet without a history of symptomatic cardiac disease will be asked to participate. All patients receive a proper therapeutic advice before randomization. Half of the recruited patients will enter the 'control group' and only receive CT calcium scoring. The other half of the recruited patients (index group) will undergo the non invasive cardiac imaging algorithm followed by evidence-based treatment. First patients undergo CT calcium scoring and CT angiography. Patients with a left main (or equivalent) coronary artery stenosis on CT angiography will be referred to a cardiologist without further imaging. All other patients in this group will undergo Dobutamine Stress Magnetic Resonance (DSMR) testing. Patients with a DSMR positive for ischemia will also be referred to a cardiologist. Most referred patients will very likely undergo conventional coronary artery angiography and cardiac interventions (CABG or PCI) if indicated. All participants of the trial will enter a 5 year follow up period for the occurrence of future cardiovascular events. Interim analysis will take place and based on power calculations about 1200 patients are needed to reach significance.
Implications The GROUND study will provide new insight into the question whether non-invasive cardiac imaging reduces the risk of cardiovascular events in patients with peripheral arterial disease, but yet without symptoms of coronary artery disease as an example of a high risk patient group.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Cardiac Imaging + Treatment
- Keywords
- peripheral arterial disease, computed tomography, cardiac asymptomatic, dobutamine magnetic resonance imaging
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Imaging + TreatmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular mortality
cardiovascular morbidity
Secondary outcomes (9)
Fatal and non-fatal myocardial infarction
Fatal and non-fatal stroke
Vascular interventions
Amputation
Aortic rupture
End stage renal failure
Extra cranial hemorrhage
Complications of CABG or PTCA
All cause mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJan 2005
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Research Office Imaging Division
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Clinical Research Office Imaging Division, UMC Utrecht
- Investigators
- W. Mali, PhD, Principal investigator, UMC UtrechtM. Oudkerk, PhD, Principal investigator, University Medical Center GroningenM.L. Bots, PhD, Principal investigator, Julius Center, University Medical Center UtrechtF. Zijlstra, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189111
- Sponsor's protocol ID
- METC.2004.100-GROUND
- Status last verified
- Nov 2016
- First submitted
- 12 Sep 2005
- Last updated
- 15 Feb 2018
- Results posted
- No
Publications
de Vos AM, Rutten A, van de Zaag-Loonen HJ, Bots ML, Dikkers R, Buiskool RA, Mali WP, Lubbers DD, Mosterd A, Prokop M, Rensing BJ, Cramer MJ, van Es HW, Moll FL, van de Pavoordt ED, Doevendans PA, Velthuis BK, Mackaay AJ, Zijlstra F, Oudkerk M. Non-invasive cardiac assessment in high risk patients (The GROUND study): rationale, objectives and design of a multi-center randomized controlled clinical trial. Trials. 2008 Aug 1;9:49. doi: 10.1186/1745-6215-9-49.
PubMed 18673542
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Cardiac Screening in High Risk Patients -The GROUND Study
- ClinicalTrials.gov ID
- NCT00189111
- Acronym / sponsor ID
- METC.2004.100-GROUND
- Conditions
- Peripheral Arterial Disease
- Keywords
- peripheral arterial disease, computed tomography, cardiac asymptomatic, dobutamine magnetic resonance imaging
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Clinical Research Office Imaging DivisionUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Apr 2012 (actual)
- First posted
- 16 Sep 2005 (estimated)
- 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 purpose of this study is to find out if subjecting cardiac high risk patients to non invasive cardiac imaging, followed by treatment will improve survival and quality of life
Detailed description
Peripheral arterial disease (PAD) is a common disease associated with a considerably increased risk of future events and with a high prevalence of coronary artery disease (CAD). Improvement of the prognosis of this patient group is needed. Screening for CAD has become an option with recent developments in CT-angiography and MR stress testing. It is unknown if high-risk patient groups benefit from screening through non-invasive cardiac imaging. Therefore we propose to study whether a cardiac imaging algorithm, using non-invasive imaging techniques followed by evidence-based treatment will reduce the risk of cardiovascular disease in cardiac asymptomatic PAD patients.
The GROUND study is designed as a prospective, multi-center, randomized clinical trial. Patients with peripheral arterial disease, but yet without a history of symptomatic cardiac disease will be asked to participate. All patients receive a proper therapeutic advice before randomization. Half of the recruited patients will enter the 'control group' and only receive CT calcium scoring. The other half of the recruited patients (index group) will undergo the non invasive cardiac imaging algorithm followed by evidence-based treatment. First patients undergo CT calcium scoring and CT angiography. Patients with a left main (or equivalent) coronary artery stenosis on CT angiography will be referred to a cardiologist without further imaging. All other patients in this group will undergo Dobutamine Stress Magnetic Resonance (DSMR) testing. Patients with a DSMR positive for ischemia will also be referred to a cardiologist. Most referred patients will very likely undergo conventional coronary artery angiography and cardiac interventions (CABG or PCI) if indicated. All participants of the trial will enter a 5 year follow up period for the occurrence of future cardiovascular events. Interim analysis will take place and based on power calculations about 1200 patients are needed to reach significance.
Implications The GROUND study will provide new insight into the question whether non-invasive cardiac imaging reduces the risk of cardiovascular events in patients with peripheral arterial disease, but yet without symptoms of coronary artery disease as an example of a high risk patient group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with peripheral arterial disease, diagnosed by the vascular surgeon
- Patients must provide consent in writing after proper education and discussion with the treating physician and/or research physician
- Patients must be aged 50 years or over
Key exclusion criteria (15 listed)
- History of symptomatic cardiac disease
- Cardiac rhythm other than sinus
- Unable to sustain a breath-hold for 25 seconds
- Asthma (contraindication beta-blockers)
- Contra-indications to MRI examination.
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 |
|---|---|---|
| Cardiac Imaging + Treatment | Procedure or surgery | – |
Primary outcome
cardiovascular mortality
cardiovascular morbidity
9 secondary outcomes
Fatal and non-fatal myocardial infarction
Fatal and non-fatal stroke
Vascular interventions
Amputation
Aortic rupture
End stage renal failure
Extra cranial hemorrhage
Complications of CABG or PTCA
All cause mortality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
- Derived from this study: PubMed 18673542de Vos AM, Rutten A, van de Zaag-Loonen HJ, Bots ML, Dikkers R, Buiskool RA, Mali WP, Lubbers DD, Mosterd A, Prokop M, Rensing BJ, Cramer MJ, van Es HW, Moll FL, van de Pavoordt ED, Doevendans PA, Velthuis BK, Mackaay AJ, Zijlstra F, Oudkerk M. Non-invasive cardiac assessment in high risk patients (The GROUND study): rationale, objectives and design of a multi-center randomized controlled clinical trial. Trials. 2008 Aug 1;9:49. doi: 10.1186/1745-6215-9-49.
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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. This study is not recruiting at the moment.
W. Mali, PhD principal investigator
UMC Utrecht
M. Oudkerk, PhD principal investigator
University Medical Center Groningen
M.L. Bots, PhD principal investigator
Julius Center, University Medical Center Utrecht
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cardiac Imaging + Treatment in people with Peripheral Arterial Disease, run by Clinical Research Office Imaging Division at 5 sites in Netherlands.
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 3 inclusion and 15 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: finished, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiovascular mortality. 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?
On the ClinicalTrials.gov record for NCT00189111, which also lists 1 linked publication.
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 15 Feb 2018.