CT PerfusionVALIDITYNCT03250455
Prognostic Value of CT dynamIc Myocardial Perfusion in Patients With Obstructive Coronary Artery Stenosis
An observational study of CT Perfusion, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 5 sites in China.
Trial summary
VALIDITY is a prospective, open-label, multicenter, randomized controlled trial （ClinicalTrials.gov number）. The study was designed to evaluate the value of noninvasive anatomic CTA combined with functional CTP for the next clinical decision making and the added prognostic value of CTP beyond CTA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CT Perfusion
- What is being tested?
- CTA CTP and CTA
- How many people
- 1,748 participants
- Where
- 5 sitesChina
- Study dates
- Aug 2017to 31 Dec 2020
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with stable chest pain and diagnosed of obstructive coronary stenosis (50-90%) by CTA were enrolled.
Who may be able to join
- age ≥18 years.
- stable chest pain with obstructive coronary stenosis (50-90%) assessed by CTA.
Who cannot join
- (1) Diagnosed or suspected acute coronary syndrome (ACS) requiring hospitalization or urgent or emergent testing; Elevated troponin or creatine kinase-myocardial band (CK-MB).
- Hemodynamically or clinically unstable condition systolic blood pressure (BP) < 90 mmHg, atrial or ventricular arrhythmias, or persistent resting chest pain felt to be ischemic despite adequate therapy.
- Known CAD with prior Myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG).
- Known significant congenital, valvular (> moderate) or cardiomyopathic process (hypertrophic cardiomyopathy or reduced systolic left ventricular function (LVEF) ≤ 40%)) which could explain cardiac symptoms.
- Contraindication to undergoing CTA, including but not limited to: a. Allergy to iodinated contrast agent, b. Unable to receive beta blockers, c. creatinine ≥1.7 mg/dl or GFR≤30 ml/min , d. Pregnancy.
- Contraindication to ATP, including but not limited to: a. II or III atrioventricular block, b. bronchial asthma, c. hypotension (SBP<90mmHg), d. bronchial stenosis or bronchospasm, e. acute myocardial infarction, f. left main stenosis, g. unstable angina, h. allergy to aminophylline.
- Life expectancy < 2 years. (8) Unable to provide written informed consent or participate in long-term follow-up.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Fuwai Hospital
Beijing, Beijing Municipality, 100037
Bin Lu, MD, 86-10-88322662, blu@vip.sina.com
Yang Gao, MD, 86-10-88322651, gaoyang226@126.com
- Recruiting
Xiehe Hospital
Beijing, Beijing Municipality
Yingning Wang, MD, 86-10-13661003076, yiningpumc@163.com
Lu Lin, MD, 86-10-13520298919, linlu03@sina.com
- Not yet recruiting
Guangdong General Hospital
Guangzhou, Guangdong, 510080
Hui Liu, MD, 8613580352002, 13580352002@139.com
Hui Gu, MD, 86-0531-68776770, 18201287661@126.com
- Recruiting
Shanghai Sixth People's Hospital
Shanghai
Jiayin Zhang, MD, 86-20-18930173280, andrewssmu@msn.com
Jian Ma, MD, 86-20-18930174762, drmajian@126.com
- Not yet recruiting
General hospital of tianjin medical university
Tianjin
Zhang Zhang, MD, 15900388839, filea1249@sina.com
Dong Li, MD, 15222709990, dr_lidong@163.com
About this study
VALIDITY is a prospective, open-label, multicenter, randomized controlled trial （ClinicalTrials.gov number）. The study was designed to evaluate the value of noninvasive anatomic CTA combined with functional CTP for the next clinical decision making and the added prognostic value of CTP beyond CTA.
- Conditions
- CT Perfusion
- Being tested
- CTA CTP, CTA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTA CTPDiagnostic test
CT Angiography myocardial CT Perfusion
CTADiagnostic test
CT Angiography
| Study group | Role | What they receive |
|---|---|---|
| CTA+CTP | Not described Receives: Diagnostic Test: CTA CTP | |
| CTA only | Not described Receives: Diagnostic Test: CTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
death, myocardial infarction and unstable angina requiring hospitalization
Measured: 90 days, 6 months, 12 months, 24 months and 36 months
Secondary outcomes (4)
invasive coronary angiography and revascularization
invasive coronary angiography and PCI or CABG
Measured: 90 days, 6 months, 12 months, 24 months and 36 months
he incidence of a composite of major complications from cardiovascular procedures and testing
stroke, bleeding, anaphylaxis, renal failure
Measured: 90 days, 6 months, 12 months, 24 months and 36 months
Quality of Life
Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale
Measured: 90 days, 6 months, 12 months, 24 months and 36
total medical cost
Assess and compare total medical cost for the two diagnostic testing arms by intention to treat
Measured: 90 days and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study startAug 2017 (estimated)
- Primary completionNov 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CT PerfusionStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- 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
- 1,748 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Guangdong Provincial People's Hospital, Tianjin Medical University General Hospital
- Responsible party
- Principal investigator, Bin Lu, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Bin Lu, MD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250455
- Sponsor's protocol ID
- CIFuwaiHospital-2
- Acronym
- VALIDITY
- Status last verified
- Aug 2017
- First submitted
- 10 Aug 2017
- Last updated
- 15 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of CT dynamIc Myocardial Perfusion in Patients With Obstructive Coronary Artery Stenosis
- ClinicalTrials.gov ID
- NCT03250455
- Acronym / sponsor ID
- VALIDITY / CIFuwaiHospital-2
- Conditions
- CT Perfusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,748 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Guangdong Provincial People's Hospital, Tianjin Medical University General Hospital
- Study start
- Aug 2017 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 15 Aug 2017 (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.
VALIDITY is a prospective, open-label, multicenter, randomized controlled trial （ClinicalTrials.gov number）. The study was designed to evaluate the value of noninvasive anatomic CTA combined with functional CTP for the next clinical decision making and the added prognostic value of CTP beyond CTA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTA+CTP | – | Diagnostic Test: CTA CTP |
| CTA only | – | Diagnostic Test: CTA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with stable chest pain and diagnosed of obstructive coronary stenosis (50-90%) by CTA were enrolled.
Key inclusion criteria (2 listed)
- age ≥18 years.
- stable chest pain with obstructive coronary stenosis (50-90%) assessed by CTA.
Key exclusion criteria (7 listed)
- (1) Diagnosed or suspected acute coronary syndrome (ACS) requiring hospitalization or urgent or emergent testing; Elevated troponin or creatine kinase-myocardial band (CK-MB).
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 |
|---|---|---|
| CTA CTPCT Angiography myocardial CT Perfusion | Diagnostic test | CTA+CTP |
| CTACT Angiography | Diagnostic test | CTA only |
Primary outcome
MACE
Time frame: 90 days, 6 months, 12 months, 24 months and 36 months
death, myocardial infarction and unstable angina requiring hospitalization
4 secondary outcomes
invasive coronary angiography and revascularization
Time frame: 90 days, 6 months, 12 months, 24 months and 36 months
he incidence of a composite of major complications from cardiovascular procedures and testing
Time frame: 90 days, 6 months, 12 months, 24 months and 36 months
Quality of Life
Time frame: 90 days, 6 months, 12 months, 24 months and 36
total medical cost
Time frame: 90 days and 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2017.
- Individual participant dataSharing planned: Undecided
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Clinical Value of CT Perfusion in Peripheral Artery Disease
Peripheral Artery Disease (PAD), CT Perfusion
Recruiting
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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.
Bin Lu, MD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CT Perfusion, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 5 sites in China.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 15 Aug 2017. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Gao, MD (86-10-88328651, gaoyang226@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: 90 days, 6 months, 12 months, 24 months and 36 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 15 Aug 2017; AzTrials last refreshed its copy on 7 Nov 2026.