Ignite Creation Date:
2024-05-06 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05261464
Status:
UNKNOWN
Last Update Posted:
2022-05-17
First Post:
2022-02-06
Brief Title:
Heart Rate Controller in Computed Tomography Coronary Angiography
Sponsor:
Mahidol University
Organization:
Mahidol University
Study Overview
Official Title:
Heart Rate Controller in Computed Tomography Coronary Angiography A Randomized Controlled Trial of Metoprolol Diltiazem and Ivabradine
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Coronary computed tomography angiography CCTA is one of important non-invasive test for diagnosis of coronary artery disease Cardiac motion artifact by heart rate HR has impact on CCTA interpretation Current recommendation suggests HR reduction at less than 60 bpm with using of oral metoprolol However there are populations that are contraindicated for beta blockers There were scantly data of calcium channel blocker and ivabradine Moreover there is no data comparing these 3 drug groups within single trial This double-blinded randomized controlled trial compares oral metoprolol immediate release diltiazem immediate release and ivabradine with primary endpoint of patients percentage to achieve target HR lower than 60 bpm prior to CCTA
Detailed Description:
Coronary computed tomography angiography CCTA is one of important non-invasive test for diagnosis coronary artery disease Information of CCTA can provide information such as coronary artery lumen vessel wall degree of stenosis and component of coronary arterial plaque Most of studies in CCTA represent high negative predictive value NPV approximately 93-100 However motion artifact has impact on CCTA interpretation especially when heart rate HR at more than 70 beat-per-minute bpm Therefore HR reduction maneuver is necessary for CCTA Current recommendation suggests HR reduction at 60 bpm for best quality of CCTA imaging and to minimized duration of exposure to radiation using either beta blockers or non-dihydropyridine calcium channel blockers According to North American Society for Cardiovascular Imaging NASCI recommendation in 2016 oral beta blocker prior to CCTA in patient with HR 60 bpm is the preferred intervention The recommended oral beta blocker usually is metoprolol 50-100 mg 1 hour prior to CCTA The dosage of metoprolol must not exceed 400 mgday However there are populations that are contraindicated or need to avoid beta blockers such as uncontrolled obstructive airway disease patient with baseline SBP 100 mmHg etc Also data in many clinical trials suggested that even high dose beta blockers cant controlled HR to target prior to CCTA in some patients These pieces of information lead to alternative drugs to control HR prior to CCTA
In previous clinical trials the effective of non-dihydropyridine calcium channel blockers to control HR prior to CCTA compare to beta blockers had unclear results In one study Intravenous IV diltiazem is as effective in HR lowering to target to less than 60 bpm as IV metoprolol Another study expressed inferior result of oral verapamil 1 hour before CCTA compared to oral metoprolol However there was heterogeneity in population of metoprolol and verapamil groups According to FDA immediate release IR diltiazem has onset of action faster than verapamil IR at 30 60-120 min respectively Initial dose of diltiazem in patients with chronic stable coronary artery disease and supraventricular tachycardia is at 30 - 60 mg oral every 6 hour and not exceed 360 mgday
Another agent that started to gain more evidence in HR control is ivabradine Ivabradine has high selective and inhibitive property to If current channel which related to sinus node pace maker activity Thus other ion current channel normally doesnt get involved and doesnt have direct other cardiovascular effect From meta-analysis patients received ivabradine significantly achieving target HR to at least 65 bpm more than beta blockers group prior to CCTA OR 502 95 CI 316- 798 p 000001 I 2 20 In current recommendation dosage of ivabradine shouldnt exceed 15 mg per day in patients with heart failure and chronic stable coronary artery disease However ivabradine has contraindication in patient with atrial fibrillation andor sinus node disease which require other agent to achieve target HR prior to CCTA In current situation there is no clinical trial to compare effect of beta blocker non-dihydropyridine calcium channel blocker and Ivabradine in HR reduction to achieve target prior to CCTA
The aim of this study is to compare percentage of patients achieving target HR 60 bpm medication prior to CCTA by using oral beta blockers non-dihydropyridine calcium channel blocker and ivabradine for HR lowering Our study is double-blinded randomized controlled trial using Metoprolol immediate release as representative of beta blockers for controlled group Diltiazem immediate release as representative of non-dihydropyridine calcium channel blocker and ivabradine We blinded both investigators and patients using encapsulated drugs distribute from Sirirajs dispensary and randomly assign to our patients The secondary objective of this study is to compare side effects time to achieve target HR CCTA image quality using 5 point grade scale and modified 15-segment American College of Cardiology and American Heart Association AHA between oral Metoprolol immediate Diltiazem immediate release and ivabradine
In previous clinical trials the effective of non-dihydropyridine calcium channel blockers to control HR prior to CCTA compare to beta blockers had unclear results In one study Intravenous IV diltiazem is as effective in HR lowering to target to less than 60 bpm as IV metoprolol Another study expressed inferior result of oral verapamil 1 hour before CCTA compared to oral metoprolol However there was heterogeneity in population of metoprolol and verapamil groups According to FDA immediate release IR diltiazem has onset of action faster than verapamil IR at 30 60-120 min respectively Initial dose of diltiazem in patients with chronic stable coronary artery disease and supraventricular tachycardia is at 30 - 60 mg oral every 6 hour and not exceed 360 mgday
Another agent that started to gain more evidence in HR control is ivabradine Ivabradine has high selective and inhibitive property to If current channel which related to sinus node pace maker activity Thus other ion current channel normally doesnt get involved and doesnt have direct other cardiovascular effect From meta-analysis patients received ivabradine significantly achieving target HR to at least 65 bpm more than beta blockers group prior to CCTA OR 502 95 CI 316- 798 p 000001 I 2 20 In current recommendation dosage of ivabradine shouldnt exceed 15 mg per day in patients with heart failure and chronic stable coronary artery disease However ivabradine has contraindication in patient with atrial fibrillation andor sinus node disease which require other agent to achieve target HR prior to CCTA In current situation there is no clinical trial to compare effect of beta blocker non-dihydropyridine calcium channel blocker and Ivabradine in HR reduction to achieve target prior to CCTA
The aim of this study is to compare percentage of patients achieving target HR 60 bpm medication prior to CCTA by using oral beta blockers non-dihydropyridine calcium channel blocker and ivabradine for HR lowering Our study is double-blinded randomized controlled trial using Metoprolol immediate release as representative of beta blockers for controlled group Diltiazem immediate release as representative of non-dihydropyridine calcium channel blocker and ivabradine We blinded both investigators and patients using encapsulated drugs distribute from Sirirajs dispensary and randomly assign to our patients The secondary objective of this study is to compare side effects time to achieve target HR CCTA image quality using 5 point grade scale and modified 15-segment American College of Cardiology and American Heart Association AHA between oral Metoprolol immediate Diltiazem immediate release and ivabradine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None