Ischemic Reperfusion InjurySCRIPNCT02649309
Single-cycle Remote Ischemic Preconditioning and Postconditioning (SCRIP) Trial
A study testing RIPre and RIPost in people with Ischemic Reperfusion Injury, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
Trial summary
This trial is a 2 x 2 factorial design, double-blinded, randomized controlled trial to evaluate efficacy and safety of remote ischemic preconditioning and postconditioning in patient undergoing coronary angioplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Reperfusion Injury
- What is being tested?
- RIPre and RIPost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 370 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2015to Jul 2019
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible for percutaneous coronary intervention (elective and emergency cases)
- Age > 18-year-old
- Informed consent
Who cannot join
- Previous CABG
- Previous PCI in 1 week / treatment with thrombolysis within 30 days
- Peripheral arterial disease / A-V shunt of upper extremities (AVF for hemodialysis)
- Paresis of upper limb
- Unstable patient such as cardiogenic shock / vasopressor / IABP / cooling (hypothermia)
- Fatal cardiac arrhythmia (VT / VF)
- Chronic hypoxia
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Department of Internal Medicine
Bangkok, 10400
Nakarin Sansanayudh, MD,PhD, +6623547600 ext. 93827, dr_nakarin@hotmail.com
Kitcha Champasri, MD, +66897146969, dr.kitcha@hotmail.com
About this study
Official title: Effect of Single-cycle Remote Ischemic Preconditioning and Postconditioning on Myocardial Injury in Patients Undergoing Emergency and Elective Percutaneous Intervention in Phramongkutklao Hospital and Thammasat University
This trial is a 2 x 2 factorial design, double-blinded, randomized controlled trial to evaluate efficacy and safety of remote ischemic preconditioning and postconditioning in patient undergoing coronary angioplasty.
- Conditions
- Ischemic Reperfusion Injury
- Being tested
- RIPre, Sham-Pre, RIPost, Sham-Post
- Keywords
- Ischemic Preconditioning, Postconditioning, Angioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIPreProcedure or surgery
Preconditioning 200 mmHg x 5 minutes before procedure
Sham-PreProcedure or surgery
Sham 10 mmHg x 5 minutes before procedure
RIPostProcedure or surgery
Postconditioning 200 mmHg x 5 minutes after procedure
Sham-PostProcedure or surgery
Sham 10 mmHg x 5 minutes after procedure
| Study group | Role | What they receive |
|---|---|---|
| RIPre + RIPost | Experimental | Intervention: RIPre 200 mmHg + RIPost 200 mmHg Receives: Procedure: RIPre; Procedure: RIPost |
| RIPre + Sham | Experimental | Intervention: RIPre 200 mmHg + Sham 10 mmHg Receives: Procedure: RIPre; Procedure: Sham-Post |
| Sham + RIPost | Experimental | Intervention: Sham 10 mmHg + RIPost 200 mmHg Receives: Procedure: Sham-Pre; Procedure: RIPost |
| Sham + Sham | Sham comparator | Intervention: Sham 10 mmHg + Sham 10 mmHg Receives: Procedure: Sham-Pre; Procedure: Sham-Post |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiac Troponin-T from baseline
Measured: within 24 hours
Secondary outcomes (7)
Incidence of myocardial injury
Incidence of myocardial injury defined as > 5 times elevation of cardiac troponin from baseline in patients with normal baseline troponin and elevation of cardiac troponin > 20% in patients who have elevated baseline troponin (>99 percentile upper reference limit).
Measured: within 24 hours
Major adverse cardiovascular events (MACE) in each intervention group
MACE = composite of CV death, MI, stroke, repeat revascularization, hospitalization for heart failure.
Measured: 6 months
Incidence of myocardial injury in differrent subgroups of patient characteristics
Patient characteristics include sex, age, underlying disease, medications, indication for PCI (ACS and elective PCI), baseline cardiac enzyme and creatinine. Incidence of myocardial injury defined as > 5 times elevation of cardiac troponin from baseline in patients with normal baseline troponin and elevation of cardiac troponin > 20% in patients who have elevated baseline troponin (>99 percentile upper reference limit).
Measured: within 24 hours
Incidence of myocardial injury in patients with vs. without RIPre and RIPost
Myocardial injury defined as > 5 times elevation of cardiac troponin from baseline in patients with normal baseline troponin and elevation of cardiac troponin > 20% in patients who have elevated baseline troponin (>99 percentile upper reference limit).
Measured: 24 hours
Incidence of MACE in differrent subgroups of patient characteristics
Patient characteristics include sex, age, underlying disease, medications, indication for PCI (ACS and elective PCI), baseline cardiac enzyme and creatinine.
MACE = composite of CV death, MI, stroke, repeat revascularization, hospitalization for heart failure.
Measured: 6 months
Incidence of MACE in patients with vs. without RIPre and RIPost
Patient characteristics include sex, age, underlying disease, medications, indication for PCI (ACS and elective PCI), baseline cardiac enzyme and creatinine.
MACE = composite of CV death, MI, stroke, repeat revascularization, hospitalization for heart failure.
Measured: 6 months
Incidence of MACE in patients who have myocardial injury vs. patients who have no myocardial injury
Myocardial injury defined as > 5 times elevation of cardiac troponin from baseline in patients with normal baseline troponin and elevation of cardiac troponin > 20% in patients who have elevated baseline troponin (>99 percentile upper reference limit).
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 posted7 Jan 2016 (estimated)
- Study startOct 2015
- Primary completionMay 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Reperfusion InjuryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phramongkutklao College of Medicine and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nakarin Sansanayudh, MD,PhD, Principal investigator, Department of Internal Medicine, Phramongkutklao Hospital, Bangkok, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649309
- Sponsor's protocol ID
- PMK-SCRIP
- Acronym
- SCRIP
- Status last verified
- Aug 2018
- First submitted
- 1 Dec 2015
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Single-cycle Remote Ischemic Preconditioning and Postconditioning on Myocardial Injury in Patients Undergoing Emergency and Elective Percutaneous Intervention in Phramongkutklao Hospital and Thammasat University
- ClinicalTrials.gov ID
- NCT02649309
- Acronym / sponsor ID
- SCRIP / PMK-SCRIP
- Conditions
- Ischemic Reperfusion Injury
- Keywords
- Ischemic Preconditioning, Postconditioning, Angioplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Phramongkutklao College of Medicine and HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- May 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 7 Jan 2016 (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.
This trial is a 2 x 2 factorial design, double-blinded, randomized controlled trial to evaluate efficacy and safety of remote ischemic preconditioning and postconditioning in patient undergoing coronary angioplasty.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RIPre + RIPost | Experimental | Procedure: RIPre, Procedure: RIPostIntervention: RIPre 200 mmHg + RIPost 200 mmHg |
| RIPre + Sham | Experimental | Procedure: RIPre, Procedure: Sham-PostIntervention: RIPre 200 mmHg + Sham 10 mmHg |
| Sham + RIPost | Experimental | Procedure: Sham-Pre, Procedure: RIPostIntervention: Sham 10 mmHg + RIPost 200 mmHg |
| Sham + Sham | Sham comparator | Procedure: Sham-Pre, Procedure: Sham-PostIntervention: Sham 10 mmHg + Sham 10 mmHg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eligible for percutaneous coronary intervention (elective and emergency cases)
- Age > 18-year-old
- Informed consent
Key exclusion criteria (7 listed)
- Previous CABG
- Previous PCI in 1 week / treatment with thrombolysis within 30 days
- Peripheral arterial disease / A-V shunt of upper extremities (AVF for hemodialysis)
- Paresis of upper limb
- Unstable patient such as cardiogenic shock / vasopressor / IABP / cooling (hypothermia)
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 |
|---|---|---|
| RIPrePreconditioning 200 mmHg x 5 minutes before procedure | Procedure or surgery | RIPre + RIPost, RIPre + Sham |
| Sham-PreSham 10 mmHg x 5 minutes before procedure | Procedure or surgery | Sham + RIPost, Sham + Sham |
| RIPostPostconditioning 200 mmHg x 5 minutes after procedure | Procedure or surgery | RIPre + RIPost, Sham + RIPost |
| Sham-PostSham 10 mmHg x 5 minutes after procedure | Procedure or surgery | RIPre + Sham, Sham + Sham |
Primary outcome
Change in cardiac Troponin-T from baseline
Time frame: within 24 hours
7 secondary outcomes
Incidence of myocardial injury
Time frame: within 24 hours
Major adverse cardiovascular events (MACE) in each intervention group
Time frame: 6 months
Incidence of myocardial injury in differrent subgroups of patient characteristics
Time frame: within 24 hours
Incidence of myocardial injury in patients with vs. without RIPre and RIPost
Time frame: 24 hours
Incidence of MACE in differrent subgroups of patient characteristics
Time frame: 6 months
Incidence of MACE in patients with vs. without RIPre and RIPost
Time frame: 6 months
Incidence of MACE in patients who have myocardial injury vs. patients who have no myocardial injury
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Individual participant dataSharing planned: Yes
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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.
Nakarin Sansanayudh, MD,PhD principal investigator
Department of Internal Medicine, Phramongkutklao Hospital, Bangkok, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIPre and RIPost in people with Ischemic Reperfusion Injury, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
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 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 31 Aug 2018. 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 Thailand. 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. Some participants in this study may receive a placebo. 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 Nakarin Sansanayudh, MD,PhD (+6627639300 ext. 93807, dr_nakarin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiac Troponin-T from baseline (time frame: within 24 hours). 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 31 Aug 2018.