Heart Rate Controller in Computed Tomography Coronary Angiography

NCT05261464 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: Si047/2021
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Rate; Coronary Computed Tomography Angiography

Keywords

coronary computed tomography angiography (CCTA); Target Heart rate

Outcome Measures

Primary Outcomes (1)

• Percent of patient achieving target heart rate (HR)

  To compare percentage of patient in achieving adequate HR control (defined as target HR of 60 bpm) among oral Ivabradine, metoprolol and diltiazem during CCTA

  3 hours

Secondary Outcomes (3)

• Side effects

  3 hours

• Time to achieve target HR

  3 hours

• Image quality

  1 week

Study Arms (3)

Metoprolol protocol

ACTIVE COMPARATOR

1. Metoprolol tartrate 50 mg will be given if patient's HR is more than 60 bpm. 2. Monitor BP and heart rate HR every 15 minute to assess targeted HR and side effects until patient's is sent to CCTA. 3. If patient can not reach targeted HR (less than 60 bpm) at 30 minutes, then second dose of 50-mg metoprolol will be given. 4. If patient can not reach targeted HR at next 30 minutes, then third dose of 50-mg metoprolol will be given. 5. If patient can not reach targeted HR at next 30 minutes, then fourth dose of 50-mg metoprolol will be given. 6. If patient's HR reach targeted HR for 15 minutes apart for 2 times or received total dose of 200 mg metoprolol tartrate, then total time will be recorded and patient will proceed to CCTA. 7. If patient can not reach targeted HR according to protocol, cardiac imaging specialist will decide whether to give further medication for HR control or proceed to CCTA. Cardiac imaging specialist may be able to consult dispensary.

Drug: Metoprolol tartrate

Ivabradine protocol

EXPERIMENTAL

1. Ivabradine 5 mg will be given if patient's HR is more than 60 bpm. 2. Monitor BP and heart rate HR every 15 minute to assess targeted HR and side effects until patient's is sent to CCTA. 3. If patient can not reach targeted HR (less than 60 bpm) at 30 minutes, then second dose of 5-mg Ivabradine will be given. 4. If patient can not reach targeted HR at next 30 minutes, then third dose of 5-mg Ivabradine will be given. 5. If patient can not reach targeted HR at next 30 minutes, then placebo will be given. 6. If patient's HR reach targeted HR for 15 minutes apart for 2 times or received total dose of 15 mg ivabradine with 1 dose of placebo, then total time will be recorded and patient will proceed to CCTA. 7. If patient can not reach targeted HR according to protocol, cardiac imaging specialist will decide whether to give further medication for HR control or proceed to CCTA. Cardiac imaging specialist may be able to consult dispensary.

Drug: Ivabradine

Diltiazem protocol

EXPERIMENTAL

1. Diltiazem immediate release (IR) 30 mg will be given if patient's HR is more than 60 bpm. 2. Monitor BP and heart rate HR every 15 minute to assess targeted HR and side effects until patient's is sent to CCTA. 3. If patient can not reach targeted HR (less than 60 bpm) at 30 minutes, then second dose of 30-mg diltiazem will be given. 4. If patient can not reach targeted HR at next 30 minutes, then third dose of 30-mg diltiazem will be given. 5. If patient can not reach targeted HR at next 30 minutes, then fourth dose of 30-mg diltiazem will be given. 6. If patient's HR reach targeted HR for 15 minutes apart for 2 times or received total dose of 120 mg 30-mg diltiazem IR, then total time will be recorded and patient will proceed to CCTA. 7. If patient can not reach targeted HR according to protocol, cardiac imaging specialist will decide whether to give further medication for HR control or proceed to CCTA. Cardiac imaging specialist may be able to consult dispensary.

Drug: Diltiazem

Interventions

Metoprolol tartrate DRUG

Prescribe oral metoprolol tartrate according to doses and time duration until patient reach targeted HR of less than 60 bpm or maximize dose according to each drug protocols prior to CCTA.

Metoprolol protocol

Ivabradine DRUG

Prescribe oral ivabradine according to doses and time duration until patient reach targeted HR of less than 60 bpm or maximize dose according to each drug protocols prior to CCTA.

Ivabradine protocol

Diltiazem DRUG

Prescribe oral diltiazem immediate-release according to doses and time duration until patient reach targeted HR of less than 60 bpm or maximize dose according to each drug protocols prior to CCTA.

Diltiazem protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of at least 18 year-old
• Received Coronary CT angiography at Siriraj Hospital to evaluate diagnosis of coronary artery disease or risk stratification of coronary artery disease
• Normal sinus rhythm with baseline HR \> 60 bpm which cardiac imaging specialist suggest using HR lowering intervention

You may not qualify if:

• Atrial fibrillation
• Previous pacemaker implantation
• II- and III-degree atrio-ventricular-block
• NHYA class III - IV
• Documented LVEF \< 40%
• Contraindication for CCTA: Impaired renal function (serum creatinine \> 1.5 mg/dl), known allergy to iodinated contrast media, pregnancy, thyroid disease
• Blood pressure \< 100/70 mmHg
• Uncontrolled asthma and/or chronic obstructive pulmonary disease (defined as GOLD stage D) and/or uncontrolled reactive airway disease
• Current medication which cause severe interaction with calcium channel blocker, beta blocker and/or Ivabradine
• Known allergy to calcium channel blocker, beta blocker and/or Ivabradine

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Department of Internal Medicine, Faculty of Medicine, Siriraj Hospital Mahidol University

Bangkok, Bangkoknoi, 10700, Thailand

RECRUITING

Related Publications (21)

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MeSH Terms

Interventions

Metoprolol; Ivabradine; Diltiazem

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Prichapol Thantassanee, M.D.

  Department of Internal Medicine, Faculty of Medicine, Siriraj Hospital Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prichapol Thantassanee, M.D.

CONTACT

+66896754200; char_uc0093@hotmail.com

Thananya Boonyasirinant, M.D.

CONTACT

+66860173767; drthananyaa@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: We blinded both investigators and patients using encapsulated drugs distribute from Siriraj's dispensary and randomly assign to our patients. These encapsulated drugs then were sealed from humidity and kept at temperature below 25 degree celsius . These drugs will not be kept for more than 1 week after encapsulated. These encapsulated were assigned according to serial number generate from nQuery program by pharmacist Siriraj's dispensary. In each package, the number from first to fourth encapsulated drugs were assigned from Siriraj's dispensary in order to prescribe to patient when HR can not reach target prior to CCTA.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. Extract patients who undergo routine Computed Tomography Coronary Angiography (CCTA) with heart rate (HR) \> 60 bpm at rest 2. Enroll patients using Inform consent from the first date of study period until reach the required sample size 3. Randomize patients to 1:1:1 using 6 block randomization by nQuery program 4. Assign sequential encapsulated drugs distribute from Siriraj's dispensary to patients according to randomization and protocol prior to CCTA. 5. Assigned encapsulated until patient reaches target HR or until full dose according to each drugs protocol prior to CCTA. 6. Continuous monitor blood pressure and heart rate every 15 minutes and closed observe side effects and complication until at least 1 hr after finish CCTA. 7. Review medical record and CCTA results, then fill in case record forms.

Study Record Dates

• First Submitted: February 6, 2022
• First Posted: March 2, 2022
• Study Start: January 30, 2021
• Primary Completion: June 20, 2022
• Study Completion: June 30, 2022
• Last Updated: May 17, 2022

Record last verified: 2022-05

Locations

TH (1)